Board of Pharmacy minutes (08/24-25/09)

New Mexico Board of Pharmacy Regular Board Meeting
August 24th & 25th, 2009
Monday August 24th, 2009
PLACE AND TIME: The Meeting was held at the Ruidoso Convention Center, 111 Sierra Blanca Dr. Ruidoso, New Mexico.
CALL TO ORDER: The meeting was called to order by the Chairman Danny Cross,
R. Ph., at 9: 00 a. m.
MEMBERS PRESENT: Danny Cross, R. Ph., Chairman
Amy Buesing R. Ph., Member
Allen Carrier, Secretary
Thomas Ortega R. Ph., Member
Ray Nunley. Member
Richard Mazzoni, Member
Howard Shaver Public Member
Joe Anderson, Member
Buffie Saavedra, Public Member ( Monday August 24th only)
MEMBERS ABSENT: Buffie Saavedra, Public Member ( Tuesday August 25th only)
STAFF ATTENDING: Mary Smith, Assistant Attorney General
William Harvey, Executive Director
Debra Wilhite, Administrative Secretary
Maria Gonzales, Administrative Assistant
ROLL CALL:
Mr. Cross took roll call at 9: 05 a. m. Present were Mr. Ortega, Ms. Buesing, Ms. Saavedra, Mr. Mazzoni, Mr. Nunley, Mr. Shaver and Mr. Anderson. The Chairman stated that Mr. Carrier would be running late.
Mr . Harvey introduced the two new board members Mr. Ray Nunley and Mr. Richard Mazzoni.
Mr. Nunley stated that he wanted to give a thank you out to Long’s Pharmacy, Walgreens, and Wal- Mart for all the snacks and refreshments.
APPROVAL OF THE AGENDA:
The Chairman asked if there were any changes to the agenda. Mr. Harvey stated that there were two additions to the public requests letters “ m” pharmacists prescriptive authority and “ n” private/ clinic practice.
Motion:
A motion was made by Ms. Buesing, seconded by Mr. Shaver to approve the changes to the agenda. The board voted unanimously to pass the motion.
APPROVAL OF THE JUNE 15TH & 16TH, 2009 MEETING MINUTES:
The Chairman asked if there were any changes to the minutes. There were no changes to the minutes.
Motion:
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A motion was made by Mr. Ortega, seconded by Ms. Saavedra to approve minutes as presented. The Board voted unanimously to pass the motion.
COMMITTEE REPORTS:
Tele- pharmacy Committee: Ms. Saavedra discussed the new rule 16.19.33 NMAC with the board regarding any comments.
Motion:
A motion was made by Mr. Ortega, seconded by Ms. Saavedra to notice 16.19.33 NMAC at the October 2009 board meeting. The board voted unanimously to pass the motion.
TITLE 16 OCCUPATIONAL AND PROFESSIONAL LICENSING
CHAPTER 19 PHARMACISTS
PART 33 TELE- PHARMACY AND REMOTE DISPENSING
16.19.33.1 ISSUING AGENCY: Regulation and Licensing Department - Board of Pharmacy.
16.19.33.2
SCOPE: This section applies to hub pharmacies and remote tele- pharmacies. Both the hub pharmacy and all remote tele- pharmacies must be located within New Mexico. The remote tele- pharmacy must be greater than 25 miles from an existing community pharmacy to qualify under these rules.
16.19.33.3 STATUTORY AUTHORITY: Section 61- 11- 6( A)( 6) NMSA 1978 requires that the Board of Pharmacy provide for the licensing of retail pharmacies and nonresident pharmacies and for the inspection of their facilities and activities. Section 61- 11- 6( A)( 1) NMSA 1978 requires the Board of Pharmacy to adopt, amend or repeal rules and regulations necessary to carry out the provisions of the Pharmacy Act.
16.19.33.4 DURATION: Permanent
16.19.33.5 EFFECTIVE DATE: ( Set date), unless a later date is cited at the end of a section.
16.19.33.6 OBJECTIVE: The objective of Part 33 of Chapter 19 is to ensure the safe and competent delivery of quality pharmaceutical products and the provision of pharmaceutical care to the public by establishing standards for the operation of remote dispensing sites and tele- pharmacy, including but not limited to minimum space requirements and standards for equipment, accessories, personnel, dispensing, labeling.
16.19.33.7 PURPOSE: The Board of Pharmacy is responsible for maintaining, continuing and enhancing the development of the education and professional role of the pharmacist for the protection of the health, welfare and safety of the citizens of New Mexico. New Mexico is facing a pharmacy services accessibility problem due to the closing of pharmacies and the lack of registered pharmacists. In order to maintain or
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make pharmacy services available in communities that have no licensed pharmacy or are in jeopardy of losing their licensed pharmacy, rules are necessary to permit remote tele- pharmacy services and remote dispensing.
16.19.33.8
DEFINITIONS:
A.
“ Average Number of Prescriptions Filled per Day ( ANPFD) means the total number of prescriptions filled during a calendar month divided by the total number of days open that month.
B. “ Electronic Link” means a real time, continuous computer, video and audio link between the hub pharmacy and the remote tele- pharmacy during all hours of operation and in compliance with 16.19.33.9A( 4).
C. “ Continuous video supervision” means a constant live video link with not less than 4 camera views which allows for real time live monitoring of the remote Tele- pharmacy remote dispensing site which is recorded for a minimum of 180 days.
D. “ Patient- Pharmacist Audio Visual Link” means a real time audio visual link from the private patient counseling area of the remote tele- pharmacy to the pharmacist at the hub pharmacy
E.
“ Hub Pharmacy” means a New Mexico licensed pharmacy operating under the direct control of a pharmacist from which computer- aided pharmacist supervision of a remote tele- pharmacy occurs.
F. “ Hub Pharmacist” means a New Mexico registered pharmacist who oversees the day to day operations of a remote tele- pharmacy via an electronic link that includes provisions for visual observations and inspection of the inside of the pharmacy and all prescription orders prior to dispensing. This oversight to include visual inspection of and patient consultation for any prescription order dispensed from the remote tele- pharmacy.
G.. “ Pharmacist- in- Charge” means the pharmacist- in- charge for the hub pharmacy from which the hub pharmacist oversees the day- to- day operation of a remote tele- pharmacy and who shall comply with 16 NMAC 19.6.9.
H.. “ Pharmacist site visits”: defines how often a pharmacist must physically visit the
remote tele- pharmacy.
- at least once a month when the ANPFD is 1 to 50,
- at least once every two weeks when the ANPFD is 51 to 100 per day,
- at least once per week when the ANPFD is 101 to 150,
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- at least twice per week when the ANPFD is 151 to 200.
- a pharmacist is required on site full time during normal operating hours
if the ANPFD exceeds 200.
I. “ Remote Dispensing Site” means a pharmacy location primarily staffed by technicians and remote dispensing technology “ Electronic Link” and continuous video supervision with required supervision and in person visits from the hub pharmacy pharmacist.
J. “ Remote Tele- Pharmacy” means a licensed pharmacy located in the State of New Mexico staffed by a remote tele- pharmacy technician who practices under the direct, computer aided, and supervision of a hub pharmacist working from the hub pharmacy by electronic link during all hours of operation.
K. “ Remote Tele- Pharmacy Technician” means a New Mexico registered pharmacy technician, employed by the hub pharmacy, with a minimum of two- thousand hours of experience working, as a certified registered pharmacy technician who, under the computer aided supervision of an off- site pharmacist, handles the day to day operation of a remote tele- pharmacy, including the preparation and dispensing of prescription drugs.
L. “ Practice of Tele- pharmacy” means the provision of pharmacist care by registered pharmacies and pharmacists through the use of telecommunications or other technologies to patients or their agents at a remote site.
16.19.33.9 OPERATIONS
A.
A remote tele- pharmacy shall comply with all sections of NMAC 16.19.6.8 governing the procedure for obtaining a license to operate a pharmacy in New Mexico:
( 1)
The license holder of the hub pharmacy must apply for a license to operate a remote tele- pharmacy. A remote tele- pharmacy license is established for the purpose of conducting a remote tele- pharmacy. The license is issued to a remote tele- pharmacy connected to a hub pharmacy via an electronic link. The initial licensure fee and subsequent license renewal fee are the same as those for retail pharmacies, as required by 16NMAC 19.12.13E.
( 2)
A remote tele- pharmacy that operates under different ownership than the hub pharmacy; to which it is attached; shall have a written
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a.
The applicant must provide sufficient evidence that the proposed location is in an area of the State lacking access to a retail pharmacy. The Board will utilize the evidence supplied by the applicant and from other sources when making a determination that sufficient evidence exists to approve an application for a remote tele- pharmacy.
( 3)
A remote tele- pharmacy shall comply with all the applicable requirements for a pharmacy as contained in NMAC 16.19 Part 6. Pharmacies.
( 4)
A remote tele- pharmacy shall be connected to a hub pharmacy via an electronic link. All links must be fully operational during all hours of operation of the remote tele- pharmacy. If any link malfunctions, the remote tele- pharmacy must be closed unless a pharmacist is physically present at the remote pharmacy site.
a.
Video equipment must be capable of providing an adequate number of simultaneous views of the pharmacy operation at the remote tele- pharmacy.
b.
The video equipment at the remote tele- pharmacy site must be capable of resolution sufficient to allow for pharmacist identification of medication dosage forms and the reading of bottle labels via video camera.
c.
The video link between a hub pharmacy and a remote tele- pharmacy site must be capable of recording and maintaining at least one hundred eighty ( 180) days of video surveillance of the remote tele- pharmacy site and operations for future review.
d.
Only a remote tele- pharmacy technician designated for that site or a pharmacist who is physically present at the remote tele- pharmacy may access a remote tele- pharmacy site, linked to a hub pharmacy via an electronic link.
e.
The remote tele- pharmacy may only remain open as long as the designated pharmacy technician is present in the remote tele- pharmacy and the hub pharmacist is present at the hub pharmacy or at the remote site.
f.
The name of each certified pharmacy technician that works at a remote tele- pharmacy shall be recorded with the New Mexico Board of Pharmacy. Notification of any change of staff at a remote tele- pharmacy shall be made to the Board of Pharmacy immediately. 5
( 5)
The pharmacist in charge of the hub pharmacy shall produce a policy and procedure for the safe and effective operation of the remote tele- pharmacy and the oversight by the hub pharmacy. This manual shall be available for Board inspection in both the remote tele- pharmacy and the hub pharmacy. The policy and procedure manual shall be reviewed by the pharmacist- in- charge annually and revised if necessary to promote improvements in safety and service at the remote tele- pharmacy. The annual review and any changes to the manual shall be documented.
( 6)
The pharmacist- in- charge is responsible for an ongoing review of incident reports and outcomes, with appropriate corrective action taken.
( 7)
A pharmacist employed by the hub pharmacy must visit and complete inspections of the remote tele- pharmacy according to the visitation requirements of 16.19.33.8. H. A list of inspection criteria shall be included in the policy and procedure manual for the remote tele- pharmacy. The pharmacist’s inspection shall include a determination of the average number of prescriptions filled per day. A copy of the inspection report shall be reviewed and signed by the pharmacist- in- charge of the hub pharmacy and a copy of the inspection report shall be maintained at both the remote tele- pharmacy and at the hub pharmacy for Board of Pharmacy inspection.
( 8)
The number of pharmacy technicians that a hub pharmacist may oversee shall be limited according to NMAC 16.19.22.10. Any pharmacy technicians on duty at the hub pharmacy site shall be taken into account along with any remote tele- pharmacy technicians working at remote tele- pharmacy sites, when computing the ratio of pharmacists to pharmacy technicians. Application for an increase in the ratio of pharmacy technicians to pharmacists may be made in accordance with NMAC 16.19.22.10B.
( 9)
A remote tele- pharmacy may have a dangerous drug inventory. Any controlled substances shall be kept at the remote site in accordance with NMAC 16.19.20.
a.
If controlled substances are kept, the remote tele- pharmacy shall be registered with the Drug Enforcement Administration and obtain its own DEA number.
b.
If controlled substances are kept, the remote tele- pharmacy shall have a valid New Mexico Controlled Substance Registration as required in NMAC 16.19.20.
c.
All controlled substances kept in inventory by the remote tele- pharmacy shall be listed on a perpetual inventory log, which shall be updated upon the dispensing of each controlled substance prescription or other disposition.
d.
The pharmacist shall perform monthly audits of all controlled substances during regular inspection visits to the remote tele- pharmacy. 6
( 10)
Prescriptions may be received, entered and filled or re- filled by the hub pharmacy and sent to the remote tele- pharmacy for distribution to the patient during hours when the technician is present in the remote tele- pharmacy. A pharmacist at the hub pharmacy must approve each prescription before it leaves the remote tele- pharmacy site.
a.
The pharmacist’s initials and the technician’s initials shall be recorded.
b.
The pharmacist shall compare the stock bottle, the drug dispensed, and drug strength. The entire prescription label must be checked for accuracy. All prescriptions distributed by the remote tele- pharmacy must have the label affixed to the prescription container prior to being inspected by the pharmacist via electronic link.
( 11)
Patient counseling shall be done by a pharmacist via an electronic link. The pharmacist shall counsel the patient or the patient’s agent on all new prescriptions and refills. All counseling, according to 16NMAC19.4.16E, remains the responsibility of the pharmacist at the hub pharmacy via an electronic link.
The chairman stated that Mr. Carrier was present at 10: 08 a. m.
APPLICATIONS:
Application List:
Clinic:
Mr. Carrier stated that there are 9 applications in this category and all are in order.
Motion:
A motion was made by Mr. Carrier, seconded by Mr. Ortega to approve all 9 applications in this category as presented. The board voted unanimously to pass the motion.
Animal Control:
Mr. Carrier stated that there is one application in this category and is in order.
Motion:
A motion was made by Mr. Carrier, seconded by Ms. Saavedra to approve the one application in this category as presented. The board voted unanimously to pass the motion. Mr. Ortega abstained from the vote.
Home Healthcare:
Mr. Carrier stated that there is one application in this category and is in order.
Motion:
A motion was made by Mr. Carrier, seconded by Ms. Buesing to approve the one application in this category as presented. The board voted unanimously to pass the motion. 7
Limited Drug Researcher:
Mr. Carrier stated that there is one application in this category and is in order.
Motion:
A motion was made by Mr. Carrier, seconded by Mr. Ortega to table the one application in this category as presented until the licensing manager Sarah Trujillo was contacted to clarify the schedules listed for this license. The board voted unanimously to pass the motion.
Motion:
A motion was made by Mr. Carrier, seconded by Mr. Ortega to approve the one application in this category after speaking with Ms. Trujillo and clarifying the schedules for this application are 1, 2, and 2N. The board voted unanimously to pass the motion.
Emergency Medical Services:
Mr. Carrier stated that there is one application in this category and is in order.
Motion:
A motion was made by Mr. Carrier, seconded by Ms. Buesing to approve the one application in this category as presented. The board voted unanimously to pass the motion.
Custodial/ Nursing Home:
Mr. Carrier stated that there are 14 applications in this category and all are in order.
Motion:
A motion was made by Mr. Carrier, seconded by Mr. Shaver to approve the 14 applications in this category as presented. The board voted unanimously to pass the motion.
Hospital:
Mr. Carrier stated that there are 3 applications in this category and all are in order.
Motion:
A motion was made by Mr. Carrier, seconded by Mr. Nunley to approve the 3 applications in this category as presented. The board voted unanimously to pass the motion.
Pharmacy:
Mr. Carrier stated that there are 7 applications in this category and all are in order.
Motion:
A motion was made by Mr. Carrier, seconded by Mr. Ortega to approve the 7 applications in this category as presented. The board voted unanimously to pass the motion. Mr. Nunley abstained from the vote.
Non- Resident Pharmacy:
Mr. Carrier stated that there are 9 applications in this category and all are in order.
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Motion:
A motion was made by Mr. Carrier, seconded by Ms. Buesing to approve the 9 applications in this category as presented. The board voted unanimously to pass the motion.
Wholesaler/ Broker:
Mr. Carrier stated that there are 14 applications in this category and all are in order.
Motion:
A motion was made by Mr. Carrier, seconded by Mr. Ortega to approve the 14 applications in this category as presented and to strike the addresses on # 6, # 7, # 8, # 9 due to security issues. The board voted unanimously to pass the motion.
Pharmacist Credentialing Committee:
Mr. Carrier presented 6 applications that were discussed by the committee on August 13th and 18thth, 2009. The applications were for Carol Bailor, Deborah Carabello, Olivier Waiman, Louanne Cunico, Larry Georgeopoulos, and Quentin Florence.
Motion:
A motion was made by Mr. Carrier, seconded by Ms. Saavedra to approve the recommendations for pharmacist clinician by the credentialing committee for Deborah Caraballo, Olivier Waiman, Louanne Cunico, Larry Georgeopoulos and Quentin Florence and that the recommendations for Ms. Bailar must be completed within the next six months first before the board will consider the waiver request made by her to the board. The board voted unanimously to pass the motion.
Motion:
A motion was made by Ms. Buesing, seconded by Mr. Anderson to note that Mr. Ortega abstained from the vote. The board voted unanimously to pass the motion. For Carol Bailar
Motion:
A motion was made Mr. Carrier, seconded by Ms. Saavedra to approve the recommendations for prescriptive authority by the credentialing committee for Deborah Caraballo, Olivier Waiman and to table Quentin Waiman until his updated protocol including QA program of practice has been received. The board voted unanimously to pass the motion.
Motion:
A motion was made by Mr. Carrier, seconded by Ms. Buesing to attach the lists to the minutes. The board voted unanimously to pass the motion.
NEW MEXICO BOARD OF PHARMACY
REGULAR MEETING
APPLICATION LIST
August 24 & 25, 2009
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CLINIC CONSULTANT PHARMACIST
1. Albuquerque Health Services- NE Clinic Change of Ownership
112 Monroe Street NE Candice Morrow, R. Ph.
Albuquerque, NM 87108
2. Albuquerque Health Services- NW Clinic New
172 Montano NW Candice Morrow, R. Ph.
Albuquerque, NM 87120
3. Fresenius Medical Care Rio Rancho Relocation
1760 Grande Blvd # 100 Wilfred Chavez, R. Ph.
Rio Rancho, NM 87124
4. Fresenius Medical Care Gibson Change of Ownership
5400 Gibson SE # 100 1st Floor Wilfred Chavez, R. Ph.
Albuquerque, NM 87108
5. LCMC Surgical Clinic New
205 Sudderth Drive Deborah Christopherson, R. Ph.
Ruidoso, NM 88345
6. Planned Parenthood of New Mexico Relocation
730 St Michael’s Drive Suite 4B Constance Hyde, R. Ph.
Santa Fe, NM 87505
7. Southeast Height Center for Family Health Relocation
8200 Central Avenue Anita Sanchez, R. Ph.
Albuquerque, NM 87108
8. UNM Hospitals Adult Infusion New
1201 Camino de Salud NE Stanley Cheshire, R. Ph.
Albuquerque, NM 87106
9. WNMMG- Grants Relocation
1217 Bonita Charles Vandiver, R. Ph.
Grants, NM 87020
ANIMAL CONTROL CONSULTANT PHARMACIST
1. Grants Police Department Relocation
722 Sakelares Blvd Phil Parkhurst, R. Ph.
Grants, NM 87020
HOME HEALTHCARE CONSULTANT PHARMACIST
1. University Home Care and Hospice Relocation
933 Bradbury Suite 3082 Cynthia Lujan, R. Ph.
Albuquerque, NM 87106
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LIMITED DRUG RESEARCHER
1. Taos Police Department New
107 Civic Plaza Drive
Taos, NM 87571
EMERGENCY MEDICAL SERVICES CONSULTANT PHARMACIST
2. Rio Arriba County EMS New
1122 Industrial Park Road Christina Atwell, R. Ph.
Espanola, NM 87532
CUSTODIAL/ NURSING HOME CONSULTANT PHARMACIST
1. Active Solutions Inc New
10300 Lawton Street NW Annabel Roberts, R. Ph.
Albuquerque, NM 87114
2. Campo Behavioral Health New
424 N Mesilla Street R H Rede, R. Ph.
Las Cruces, NM 88005
3. Campo Behavioral Health New
2075 Enzie R H Rede, R. Ph.
Las Cruces, NM 88005
4. Campo Behavioral Health New
1812 Augustus R H Rede, R. Ph.
Las Cruces, NM 88005
5. Caring House New
1024 Marapi NW Evangeline Ward, R. Ph.
Albuquerque, NM 87120
6. Casa Fina Assisted Living LLC New
11921 Euclid Court NE Reynaldo Saenz, R. Ph.
Albuquerque, NM 87112
7. Cuidando Las Familias Inc New
7116 Cuchillo Road NW Reynaldo Saenz, R. Ph.
Albuquerque, NM 87114
8. Cuidando Las Familias Inc New
# 10 Rosalia Road Reynaldo Saenz, R. Ph.
Cedar Crest, NM 87008
9. Helen Castro New
403 Arrow Road Rudy Nolasco, R. Ph.
Las Vegas, NM 87701
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10. Lorencita Lopez New
42 Crawford Road Wilfred Chavez, R. Ph.
Jarales, NM 87023
11. Opti- Health New
3513 Pitt Avenue Perry Storey, R. Ph.
Albuquerque, NM 87111
12. Ramah Care Services New
1500 South 2nd Street Suite 1 Perry Storey, R. Ph.
Gallup, NM 87301
13. Silver Lining Services LLC New
1447 East Roosevelt Cyndi Reynolds, R. Ph.
Grants, NM 87020
14. Silver Lining Services LLC New
1015 Sage Cyndi Reynolds, R. Ph.
Grants, NM 87020
HOSPITAL PHARMACIST IN CHARGE
1. BHC Mesilla Valley Hospital Pharmacy Remodel
3521 Del Rey Blvd Pamela Brummal, R. Ph.
Las Cruces, NM 88012
2. Lovelace Medical Center Inpatient Pharmacy Relocation
601 Dr Martin Luther King Jr Kurt Mahan, R. Ph.
Albuquerque, NM 87102
3. Lovelace Medical Towers Outpatient Pharmacy Remodel
500 Walter Street Suite 202 Sam Sanchez, R. Ph.
Albuquerque, NM 87102
PHARMACY PHARMACIST IN CHARGE
1. K & M Lab and Pharmacy Relocation
5740 Night Whisper NW Connie Tsui, R. Ph.
Albuquerque, NM 87114
2. Total Health & Wellness Center of Taos New
622B Paseo del Pueblo Sur Jake Mossman, R. Ph.
Taos, NM 87571
3. UNMH Refill Center Relocation
1130 University NE Suite G Margaret Gallegos, R. Ph.
Albuquerque, NM 87102
4. Walgreens New 12
3990 East Lohman Avenue Mateo Delgado, R. Ph.
Las Cruces, NM 88011
5. Wal* Mart Remodel
01 I- 25 Interchange Theresa Sanchez, R. Ph.
Belen, NM 87002
6. Wal* Mart Remodel
1800 West Hwy 70 Carilyn Miller, R. Ph.
Ruidoso Downs, NM 88346
7. Wal* Mart Remodel
2330 S New York Avenue Debra Dunn, R. Ph.
Alamogordo, NM 88310
NON- RESIDENT PHARMACY PHARMACIST IN CHARGE
1. Allied Preferred New
8625 King George Drive # 300 Tommy Swayden, R. Ph.
Dallas, TX 75235
2. Commcare Pharmacy New
2817 E Oakland Park Blvd # 303 Sal Saraniti, R. Ph.
Fort Lauderdale, FL 33306- 1889
3. Costco Wholesale Corporation New
215 Deininger Circle Yong Lee, R. Ph.
Corona, CA 92880
4. Long Beach Prescription Pharmacy New
2632 Pacific Avenue Toan Thai, R. Ph.
Long Beach, CA 90806
5. Omnicare of Texas 1 LP New
DBA Omnicare of Fort Worth John Gray, R. Ph.
14450 Trinity Blvd Suite 200
Fort Worth, TX 76155
6. One Stop Pharmacy New
3193 Tech Drive Suite B Randolph Breton, R. Ph.
St Petersburg, FL 33716
7. Option Care Enterprises Inc New
10924 John Galt Blvd Erica Garris, R. Ph.
Omaha, NE 68137
8. PVPL New
10077 South 134th Street Jennifer O’Grady, R. Ph.
Omaha, NE 68138
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WHOLESALE/ BROKER
1. Abbott Laboratories Inc New
8901 Forney Road
Dallas, TX 75227
2. Comp Ray Inc New
4801 Ellison Street NE Suite J
Albuquerque, NM 87109
3. Correct Rx Pharmacy Services Inc New
803- A Barkwood Court
Linthicum, MD 21090
4. De Royal Industries Inc New
1755 HWY 33 South
New Tazewell, TN 37825
5. Diplomat Specialty Pharmacy New
2029 S Elms Road Suite G
Swartz Creek, MI 48473
6. McKesson Specialty Distribution LLC New
7. McKesson Specialty Distribution LLC New
8. McKesson Specialty Distribution LLC New
9. McKesson Specialty Distribution LLC New
10. Promotech Logistics Solutions LLC New
DBA Promotech
25 Madison Road
Totowa, NJ 07512
11. RIT Oncology LLC New
1700 Seventh Avenue Suite 2100
Seattle, WA 98101
12. Teva Women’s Health Inc New
5040 Duramed Drive
Cincinnati, OH 45213
13. United Therapeutics Corporation New
55 T W Alexander Drive
Research Triangle Park, NC 27709
14. X- Gen Pharmaceuticals Inc New
300 Daniel Zenker Drive
Horseheads, NY 14845 14
The Chairman asked for a 10- minute recess at 10: 40 a. m.
RECESS:
RECONVENE:
The board reconvened at 10: 50 a. m.
Committee Reports Cont’d:
Pharmacist Clinician Committee: Mr. D” Amour addressed issues regarding Ms. Bailar’s waiver request during approval of applications for pharmacist clinician.
Pharmacist CE Committee: Mr. Anderson stated that he and Ms. Saavedra would be sending out surveys to all licensed pharmacist to capture their input on requirements of education and the availability of types of CE’s, by November 1st, 2009, of which they will compile the information returned and inform the board when completed He also stated that the committee had voted yes to live CE being offered and that the number of hours and types were still being discussed but at least a 30 hour requirement with initial licensure. Mr. Ortega mentioned that CE on medication errors should be considered. Ms. Disco discussed “ continuous professional development” and the need for it during the licensing period.
RULE HEARING – 16.19.6 NMAC:
Mr. Harvey presented the amended language to the board from Mr. Sauceda for comment. The board and Mr. Saucedo discussed the amended changes regarding Section 11 of 16.19.6 NMAC. Mr. Harvey added the changes as requested by the board.
Motion:
A motion was made by Mr. Ortega, seconded by Ms. Buesing to approve the rule 16.19.6 NMAC as amended. The chairman took a roll call vote. Mr. Ortega, Ms. Saavedra, Ms. Buesing, Mr. Mazzoni, Mr. Carrier, Mr. Nunley, Mr. Shaver, Mr. Anderson, and Mr. Cross all voted unanimously to pass the motion. The Chairman asked that the notice be marked as exhibit # 1, amendment to the rule be marked as exhibit # 2, and the letter from Phil Saucedo be marked as exhibit # 3.
( 2) Requirements for training.
a.
All pharmacists prior to compounding sterile pharmaceuticals, or supervising pharmacy personnel compounding sterile pharmaceuticals, all shall have completed a minimum of 20 contact hours of didactic, experiential training and competency evaluation through demonstration and testing ( written or practical) as outlined by the pharmacist- in- charge and described in the policy and procedures or training manual. Such training shall be evidenced by completion of a recognized course in an accredited college of pharmacy or an ACPE approved course which shall include instruction and hands- on experience in the following areas:
i.
aseptic technique;
ii.
critical area contamination factors;
iii.
environmental monitoring;
iv.
facilities; 15
v.
equipment and supplies;
vi.
sterile pharmaceutical calculations and terminology;
vii.
sterile pharmaceutical compounding documentation;
viii.
quality assurance procedures;
ix.
proper gowning and gloving technique;
x.
the handling of cytotoxic and hazardous drugs; and
xi.
general conduct in the controlled area.
b.
All pharmacist interns prior to compounding sterile pharmaceuticals shall have completed a minimum of 40 hours of instruction and experience in the areas listed in paragraph 12. Such training will be obtained through the:
i.
completion of a structured on- the- job didactic and experiential training program at this pharmacy ( not transferable to another pharmacy); or
ii.
completion of a course sponsored by an ACPE approved provider.
iii.
certification by University of New Mexico College of Pharmacy upon graduation.
c.
All pharmacy technicians who compound sterile pharmaceuticals shall have a high school or equivalent education and be a certified pharmacy technician, and complete a minimum of 40 hours of instruction and experience in the areas listed in paragraph 12. Such training will be obtained through the:
i.
completion of a structured on- the- job didactic and experiential training program at this pharmacy ( not transferable to another pharmacy) which provides 40 hours of instruction and experience in the areas listed in paragraph 12; or
ii.
completion of a course sponsored by an ACPE approved provider which provides 40 hours of instructions and experience in the areas listed in paragraph 12.
d.
All pharmacists compounding sterile chemotherapy drugs or supervising pharmacy interns or technicians compounding sterile chemotherapy drugs shall, effective December 31, 2008, have completed a board approved training program in chemotherapy drug preparation. All pharmacy interns and technicians must complete this training prior to preparing sterile chemotherapy drug products.
Committee Reports Cont’d:
Pharmacy Technician Committee: No report at this time.
Emergency Preparedness Committee: ** partially inaudible** The board had a lengthy discussion regarding the declaration for emergency preparedness and DOH protocol. Mr. Harvey stated that the Pharmacy Act authorizes the executive director of the board of pharmacy to make decisions and carry out what may be deemed necessary to effectively provide for emergency situations.
Motion:
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A motion was made by Mr. Ortega, seconded by Ms. Buesing to accept the declaration with suggested changes and protocol as presented. The board voted unanimously to pass the motion.
The chairman asked to recess for lunch at 12: 00 noon.
RECESS FOR LUNCH:
RECONVENE:
The board reconvened at 1: 35 p. m.
PUBLIC REQUESTS:
Artesia General Hospital Waiver Request: Mr. Irby was present to discuss the waiver request with the board. The board had issues regarding the seriousness of the director of the hospital not attending as requested. The board informed Mr. Irby that they would approve the waiver only until March 2010 and expect to have representatives for the hospital, attend the March meeting.
Motion:
A motion was made by Ms. Saavedra, seconded by Mr. Nunley to approve the waiver until March 2010. The board voted unanimously to pass the motion.
Gila Hospital: Mr. Ray Goellner was present to discuss the waiver request as stated in 16.19.6 NMAC for training. After a brief discussion the board agreed to accept the waiver as presented.
Motion:
A motion was made by Ms. Saavedra, Seconded by Mr. Shaver to approve the waiver request. The board voted unanimously to pass the motion.
Aloun Mary Vilay, Pharm D – Two Waiver Requests: Mr. Harvey presented the documentation provided by Ms. Vilay regarding her waiver request based on her BS in pharmacy from the University of Alberta as well as a Doctor of Pharmacy degree from the University of Toronto including fellowship training from the University of Michigan.
Motion:
A motion was made by Ms. Saavedra, seconded by Mr. Mazzoni to approve the request of exemption from obtaining the FPGEC certification for Ms. Aloun Mary Vilay. The board voted unanimously to pass the motion. Mr. Anderson and Ms. Buesing abstained from the vote.
Motion:
A motion was made by Ms. Saavedra, seconded by Mr. Shaver to accept the intern hours as presented by Ms. Vilay as requested in the waiver. The board voted unanimously to pass the motion.
Doug Scribner – CNM IV Training for Techs: Mr. Scribner was not present. Mr. Harvey presented documentation for the waiver request regarding the sterile products training issues. After a brief discussion the board agreed to approve the request for waiver.
Motion:
A motion was made by Mr. Nunley, seconded by Mr. Shaver to approve the waiver request for sterile products training as presented via documentation by Mr. Doug Scribner. The board voted unanimously to pass the motion.
17
Sarah Garnoke, PMI – Request for Waiver: Ms. Gamoke requested that the board allow the PIMA Director to sign off on the training records for pharmacy technician students therefore requesting a waiver on the PIC signing the training record.
Motion:
A motion was made by Mr. Shaver, seconded by Ms. Buesing to approve the waiver for two years. The board voted unanimously to pass the motion.
Phil Saucedo, Executive Director NMSHP, Rule Change Request 16.19.6.11( C) 2: Mr. Saucedo presented the amended language for 16.19.6.11( C) 2) regarding the certification requirements.
Motion:
A motion was made by Ms. Buesing, seconded by Mr. Ortega to notice the amended language for 16.19.6.11( C) 2 at the October 2009 board meeting. The board voted unanimously to pass the motion.
Committee Reports Cont’d:
BOP/ Chiropractic Formulary Committee - HB 14 Formulary Effective 9/ 11/ 09: A lengthy discussion was held regarding the validity of the formulary that has been presented for filing without the approval of the board of pharmacy based on statute 61- 1- 31( A) and 61- 1- 31( B) which gives the pharmacy board the standing to challenge the filing. Because the formulary was not presented to the board and due to the nature of drugs listed and the lack of information regarding their uses, indications and listing classes of drugs as apposed to listing the names of dangerous drugs, controlled substances, vitamins and minerals, and OTC drugs, the board will contact the chiropractic board for feedback. Ms Smith stated that the pharmacy board should look into when the rule was filed, get the transcript of the noticed rule and if the board feels they should pursue the issue to file with the court of appeals. Mr. Harvey also stated that he feels that the board should inform RLD. Ms. Smith stated that she will consult with her colleagues for further direction.
Motion:
A motion was made by Mr. Shaver, seconded by Mr. Mazzoni for the board to pursue the validity of the formulary as presented by the chiropractic board due to the lack of approval by the pharmacy board before the filing of the rule referenced as being effective 9/ 11/ 09. The board voted unanimously to pass the motion.
BOP/ BAOM Education Committee – BAOM Formulary; Letter from Chairman Pieper concerning new injections- approval of education requirements: Chairman Pieper briefly discussed education requirements and concerns regarding injections. No committee report at this time as per Mr. Cross.
The chairman asked for a 10- minute break at 2: 35 p. m.
RECESS:
RECONVENE:
The board reconvened at 2: 45 p. m.
Executive Director’s Report Cont’d:
Proposed Changes/ Additions to Controlled Substances Schedule I, II, III, IV, V: Mr. Harvey presented the proposed additions of controlled substances to 16.19.20 NMAC for a final approval.
Motion:
18
A motion was made by Mr. Carrier, seconded by Ms. Saavedra to notice 16.19.20 NMAC at the October 2009 board meeting. The board voted unanimously to pass the motion.
16.19.20.65 SCHEDULE I:
A. NMSA 1978 Section 30- 31- 6 schedule I shall consist of the following drugs and other substances, by whatever name, common or usual name, chemical name or brand name designated, listed in this section; OPIATES, unless specifically exempt or unless listed in another schedule, any of the following opiates, including its’ isomers, esters, ethers, salts and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation.
( 1) Acetylmethadol
( 2) Allyl prodine
( 3) Alphacetylmethadol
( 4) Alphameprodine
( 5) Alphamethadol
( 6) Alpha- methyl fentanyl
( 7) Benzethidine
( 8) Betacetylmethadol
( 9) Betameprodine
( 10) Betamethadol
( 11) Betaprodine
( 12) Clonitazene
( 13) Dextromoramide
( 14) Diampromide
( 15) Diethylthiambutene
( 16) Dimethylthiambutene
( 17) Difenoxin
( 18) Dimenoxadol
( 19) Dimepheptanol
( 20) Dimethylthiambutene
( 21) Dioxaphetyl Butyrate
( 22) Dipipanone
( 23) Ethylmethylthiambutene
( 24) Etonitazene
( 25) Etoxeridine
( 26) Furethidine
( 27) Hydroxypethidine
( 28) Ketobemidone
( 29) Levomoramide
( 30) Levophenacylmorphan
( 31) Morpheridine
( 32) Noracymethadol
( 33) Norlevorphanol
( 34) Normethadone
( 35) Norpipanone
( 36) Phenadoxone
( 37) Phenampromide
( 38) Phenomorphan
( 39) Phenoperidine
( 40) Piritramide
( 41) Proheptazine
( 42) Properidine
( 43) Propiram
( 44) Racemoramide
( 45) Tilidine
( 46) Trimeperidine
19
B. OPIUM DERIVATIVES: Unless specifically exempt or unless listed in another schedule, any of the following opium derivatives, its’ salts, isomers, and salts of isomers whenever the existence of such salts, isomers and salts of isomers is possible within the specific chemical designation.
( 1) Acetorphine
( 2) Acetyl dihydrocodeine
( 3) Benzyl morphine
( 4) Codeine methylbromide
( 5) Codeine- N- Oxide
( 6) Cyprenorphine
( 7) Desomorphine
( 8) Dehydro morphine
( 9) Etorphine
( 10) Heroin
( 11) Hydromorphinol
( 12) Methyldesorphine
( 13) Methyldihydromorphine
( 14) Morphine methylbromide
( 15) Morphine methylsulfonate
( 16) Morphine- N- Oxide
( 17) Myrophine
( 18) Nicocodeine
( 19) Nicomorphine
( 20) Normorphine
( 21) Pholcodine
( 22) Thebacon
( 23) Drotebanol
( 24) Beta- Hydroxy- 3- Methylfentanyl
( 25) 3- Methylthiofentanyl
( 26) Acetyl- Alpha- Methyl fentanyl
( 27) Alpha- Methylthiofentanyl
( 28) Beta- hydroxfentanyl
( 29) Para- Fluoro fentanyl
( 30) Thiofentanyl
C. HALLUCINOGENIC SUBSTANCES: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation, which contains any quantity of the following hallucinogenic substances, or which contains any of its’ salts, isomers, and salts of isomers whenever the existence of such salts, isomers and salts of isomers is possible within the specific chemical designation ( for purpose of this sub- section only, the term “ isomers” includes the optical position, and geometric isomers).
( 1) 3,4 - methylenedioxy amphetamine
( 2) 5 - methoxy - 3,4- methylenedioxy amphetamine
( 3) 3,4,5 - trimethoxy amphetamine
( 4) Bufotenine
( 5) Diethyltryptamine; DET
( 6) Dimethyltryptamine; DMT
( 7) 4- methyl- 2,5- dimethoxy- amphetamine; DOM or STP
( 8) Lysergic acid diethylamide
( 9) Lysergic acid diethylamide
( 10) Marijuana
( 11) Mescaline
( 12) Peyote
( 13) N- ethyl- 3- piperidyl benzilate
( 14) N- methyl- 3- piperidyl benzilate
( 15) Psilocybin
( 16) Psilocyn
( 17) Tetrahydrocannabinols 20
( 18) Parahexyl ( synthetic analog of delta- 9- tetrahydrocannabinol ( THC) an active ingredient of cannabis)
( 19) Hashish
( 20) 2, 5 - dimethoxyamphetamine; 2, 5- DMA
( 21) 4- bromo- 2, 5- dimethoxy- amphetamine; 2,5- DMA
( 22) 4- methoxyamphetamine; PMA
( 23) Ethylamine N- ethyl- 1- phenylcyclohexylamine ( PCE)
( 24) Pyrrolidine 1-( 1- phenylcyclohexyl)- pyrrolidine ( PCPy), ( PHP) analog of the drug phencyclidine
( 25) Thiophene ( analog of phencyclidine) TCP or TPCP
( 26) Alpha- ethyltryptamine
( 27) 2, 5- dimethoxy- 4- ethylamphet- amine
( 29) Ibogaine
( 30) 2,5 dimethoxy- 4-( n)- propylthiophenethylamine ( 2C- T- 7)
( 31) Alpha- methyltryptamine ( AMT)
( 32) 5- methoxy- N, N- diisopropyltryptamine ( 5- MeO- DIPT)
D. DEPRESSANTS: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including its’ salts, isomers and salts of isomers whenever the existence of such salts, isomers and salts of isomers is possible within the specific chemical designation:
( 1) Mecloqualone
( 2) Methaqualone
( 3) Benzodiazepines
( a) bromazepam
( b) camazepam
( c) clobazam
( d) cloxazolam
( e) delorazepam
( f) ethyl loflazepate
( g) fludiazepam
( h) flunitrazepam
( i) haloxazolam
( j) ketazolam
( k) loprazolam
( l) lormetazepam
( m) medazepam
( n) nimetazepam
( o) nitrazepam
( p) nordiazepam
( q) oxazolam
( r) pinazepam
( s) tetrazepam
( 4) Gamma hydroxybutyric acid and any chemical compound that is metabolically converted to GHB.
( 5) Gamma butyrolactone and any chemical compound that is metabolically converted to GHB.
( 6) 1- 4 butane diol and any chemical compound that is metabolically converted to GHB.
E. STIMULANTS: Unless specifically exempted or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its’ salts, isomers, and salts of isomers.
( 1) Fenethylline
( 2) N- ethylamphetamine
( 3) cis- 4- methylaminorex
( 4) N, N- dimethylamphetamine
( 5) N- benzylpiperazine ( BZP, 1- benzylpiperazine) 21
F. Any material, compound, mixture of preparation which contains any quantity of the following substances.
( 1) 3- Methylfentanyl( N- 3- methyl- 1-( 2- phenyl- ethyl)- 4- Piperidyl)- N- phenylpropanamide, its’ optical and geometric isomers, salts and salts of isomers.
( 2) 3, 4- methylenedioxymethamphetamine ( MDMA), its’ optical, positional and geometric isomers, salts and salts of isomers.
( 3) 1- methyl- 4- phenyl- 4- proprionoxypiperidine ( MPPP), its’ optical isomers, salts, and salts of isomers.
( 4) 1-(- 2- phenylethyl)- 4- phenyl- 4- acetoxy piperidine ( PEPAP), its’ optical isomers, salts and salts of isomers.
( 5) Cathinone.
( 6) Methcathinone.
[ 16.19.20.65 NMAC - Rp 16 NMAC 19.20.28, 07- 15- 02; A, 06- 30- 05; A, 01- 15- 08]
16.19.20.66 SCHEDULE II:
A. Shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name or brand name designated, listed in this section. Substance, vegetable origin or chemical synthesis. Unless specifically exempt or unless listed in another schedule, any of the following substances whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis.
( 1) Opium and opiate, and any salts, compound, derivative, or preparation of opium or opiate excluding naloxone, dextrorphan, nalbuphine, naltrexone and apomorphine but including the following:
( a) raw opium
( b) opium extracts
( c) opium fluid extracts
( d) powdered opium
( e) granulated opium
( f) tincture of opium
( g) codeine
( h) ethylmorphine
( i) etorphine hydrochloride
( j) hydrocodone
( k) hydromorphone
( l) metopon
( m) morphine
( n) oxycodone
( o) oxymorphone
( p) thebaine
( q) alfentanil
( r) oripavine
( 2) Any salt, compound derivative, or preparation thereof, which is chemically equivalent or identical with any of the substances referred to in 16.19.20.66. A.( 1) NMAC, except that these substances shall not include the isoquinoline alkaloids of opium.
( 3) Opium poppy and poppy straw.
( 4) Coca leaves and any salt, compound, derivative or preparation of coca leaves and any salt, compound, derivative or preparation thereof which is chemically equivalent or identical with any of these substances, except that the substances shall not include de- cocainized coca leaves or extraction of coca leaves, which extractions do not contain cocaine or ecgonine.
B. OPIATES: Unless specifically excepted or unless in another schedule any of the following opiates, including its’ isomers, esters, ethers, salts and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation except dextrose and levopropoxyphene.
( 1) Alphaprodine
( 2) Anileridine
( 3) Bezitramide
22
( 4) Diphenoxylate
( 5) Dihydrocodeine
( 6) Dextropropoxyphene ( bulk) non- dosage form
( 7) Fentanyl
( 8) Isomethadone
( 9) Levomethorphan
( 10) Levorphanol
( 11) Metazocine
( 12) Methadone
( 13) Methadone- Intermediate
( 14) Monamide- Intermediate
( 15) Pethidine
( 16) Pethidine- Intermediate A
( 17) Pethidine- Intermediate B
( 18) Pethidine- Intermediate C
( 19) Phenazocine
( 20) Piminodine
( 21) Racemethorphan
( 22) Racemorphan
( 23) Sufentanil
( 24) Carfentanil
( 25) Levo- alphacetylmethadol ( LAAM)
( 26) Tapentadol
C. STIMULANTS: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system. ( See 16.19.21 NMAC- Drug Precursors)
( 1) Amphetamine, its’ salts, optical isomers and salts of its’ optical isomers.
( 2) Methamphetamine, its’ salts, isomers and salts of isomers.
( 3) Phenmetrazine and its’ salts.
( 4) Methylphenidate.
( 5) Lisdexamfetamine.
D. DEPRESSANTS: Unless specifically exempt or unless listed in another schedule any material, compound mixture or preparation which contains any quantity of the substance having a depressant effect on the central nervous system, including its’ salts, isomers and salts of isomers is possible within the specific chemical designation.
( 1) Amobarbital
( 2) Secobarbital
( 3) Pentobarbital
( 4) Phencyclidine
( 5) Dronabinol ( synthetic) - in sesame oil and encapsulated in soft gelatin capsules in a drug product approved by the U. S. Food and Drug Administration
( 6) Glutethimide
( 7) 1- phenylcyclohexylamine
( 8) 1- piperidinocyclohexanecarbonitrile
E. HALLUCINOGENIC SUBSTANCES: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation, which contains any quantity of the following hallucinogenic substances, or which contains any of its’ salts, isomers and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation ( for purpose of this paragraph only, the term “ isomers” includes the optical position, and geometric isomers): Nabilone
F. MISCELLANEOUS:
( 1) Dihydroetorphine
( 2) Bulk dextropropoxyphene
( 3) Remifentanil
[ 16.19.20.66 NMAC - Rp 16 NMAC 19.20.28( 1), 07- 15- 02; A, 06- 30- 05; A, 01- 15- 08]
23
16.19.20.67 SCHEDULE III: Shall Consist of Drugs and Other Substances, By Whatever Official Name, Common or Usual Name Designated Listed in This Section.
A. STIMULANTS: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system.
( 1) Those compounds, mixtures or preparations in dosage unit form containing any stimulant, amphetamine, phenmetrazine or methamphetamine previously exempt, for which the exemption was revoked by FDA Regulation Title 21, Part 308.13, and any other drug of the quantitative composition shown in that regulation for those drugs or which is the same except that it contains a lesser quantity of controlled substances.
( 2) Benzphetamine.
( 3) Phendimetrazine.
( 4) Chlorphentermine.
( 5) Clortermine.
B. DEPRESSANTS: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system.
( 1) Any compound, mixture or preparation containing:
( a) amobarbital;
( b) secobarbital;
( c) pentobarbital;
( d) butalbital; or any salt thereof and one or more active medicinal ingredients which are not listed in any schedule.
( 2) Any suppository dosage form containing:
( a) amobarbital;
( b) secobarbital;
( c) pentobarbital; or any salt of any of these drugs approved by the FDA for marketing only as a suppository.
( 3) Any substance which contains any quantity of a derivative of barbituric acid or any salt of a derivative of barbituric acid.
( 4) Chlorhexadol
( 5) Lysergic Acid
( 6) Lysergic Acid Amide
( 7) Methyprylon
( 8) Sulfondiethylmethane
( 9) Sulfonethylmethane
( 10) Sulfonmethane
( 11) Tiletamine/ zolazepam ( Telazol)
( 12) Ketamine Hydrochloride
( 13) Any drug product containing gamma hydroxybutyric acid, including its salts, isomers, and salts of isomers, for which an application is approved under section 505 of the Federal Food, Drug and Cosmetic Act.
( 14) Embutramide
C. Nalorphine ( a narcotic drug).
D. Buprenorphine.
E. NARCOTIC DRUGS: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation containing limited quantities of the following narcotic drugs, or any salts thereof.
( 1) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium.
( 2) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage units, with one or more active nonnarcotic ingredients in recognized therapeutic amounts.
( 3) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium.
( 4) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic
24
amounts.
( 5) Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
( 6) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
( 7) Not more than 500 milligrams of opium per 100 milliliters or per 100 grams or not more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
( 8) Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
F. ANABOLIC STEROIDS: The term “ anabolic steroid” means any drug or hormonal substance, chemically and pharmacologically related to testosterone ( other than estrogens, progestins, and corticosteroids) that promotes muscle growth. Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances listed in this section:
( 1) boldenone
( 2) chloro testosterone
( 3) clostebol
( 4) dehydrochlormethyltestosterone
( 5) dihydrotestosterone
( 6) drostanolone
( 7) ethylestrenol
( 8) fluoxymesterone
( 9) formebolone
( 10) mestanolone
( 11) mesterolone
( 12) methandienone
( 13) methandranone
( 14) methandriol
( 15) methandrostenolone
( 16) methenolone
( 17) methyltrienolone
( 18) methyltestosterone
( 19) mibolerone
( 20) nandrolone
( 21) norbolethone
( 22) norethandrolone
( 23) oxandrolone
( 24) oxymesterone
( 25) oxymetholone
( 26) stanolone
( 27) stanozolol
( 28) testolactone
( 29) testosterone
( 30) trenbolone; and
( 31) any salt, ester, or isomer of a drug or substance described or listed in this paragraph, if that salt, ester, or isomer promotes muscle growth.
G. Exempt Anabolic Steroids: Compounds, mixtures, or preparations that contain an anabolic steroid that have been exempted by the board from Subsection E of 16.19.20.67 NMAC, schedule III to the same extent that the substance has been exempted from the application of the Federal Controlled Substance Act, if the substance is listed as an exempt anabolic steroid product under 21 C. F. R. Section 1308.34 and its subsequent amendments.
[ 16.19.20.67 NMAC - Rp 16 NMAC 19.20.28( 2), 07- 15- 02; A, 02- 15- 03; A, 06- 30- 05; A, 01- 31- 07; A, 01- 15- 08]
25
16.19.20.68 SCHEDULE IV: Shall Consist of the Drugs and Other Substances, by Whatever Official Name, Common or Usual Name, Chemical Name, or Brand Name Designated, Listed in this Section:
A. DEPRESSANTS: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances, including its’ salts, isomers, and salts of isomers whenever the existence of such salts, isomers and salts of isomers is possible within the specific chemical designation:
( 1) Alprazolam
( 2) Barbital
( 3) Chloral Betaine
( 4) Chloral Hydrate
( 5) Chlordiazepoxide
( 6) Clonazepam
( 7) Clorazepate
( 8) Clotiazepam
( 9) Diazepam
( 10) Estazolam
( 11) Ethchlorvynol
( 12) Ethinamate
( 13) Flurazepam
( 14) Halazepam
( 15) Lorazepam
( 16) Mebutamate
( 17) Meprobamate
( 18) Methohexital
( 19) Methylphenobarbital
( 20) Midazolam
( 21) Oxazepam
( 22) Paraldehyde
( 23) Petrichloral
( 24) Phenobarbital
( 25) Prazepam
( 26) Quazepam
( 27) Temazepam
( 28) Triazolam
( 29) Zopiclone
B. FENFLURAMINE: Any material, compound, mixture or preparation which contains any quantity of the following substance, including its’ salts, isomers ( whether optical position, or geometric) and its’ salts, or such isomers, whenever the existence of such salts, isomers, and salts of isomers is possible: Fenfluramine
C. STIMULANTS: Unless specifically exempt or unless listed in another schedule any material, compound, mixture or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its’ salts, isomers ( whether optical position, or geometric) and salts of such isomers whenever the existence of such salts, isomers and salts of isomers is possible within the specific chemical designation:
( 1) Diethylpropion
( 2) Phentermine
( 3) Pemoline ( including organometallic complexes and chelates thereon)
( 4) Pipradrol
( 5) SPA ((-)- 1- dimethyl amino- 1,2- diphenylmethane)
( 6) Mazindol
( 7) Cathine
( 8) Fencamfamin
( 9) Fenproporex
( 10) Mefenorex
26
( 11) Modafinil
( 12) Sibutramine
D. OTHER SUBSTANCES: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances, including its’ salts:
( 1) Dextropropoxyphene( Alpha-(+)- 4- dimethylamino- 1,2- diphenyl- 3- methyl- 2- propionoxybutane)
( 2) Pentazocine
( 3) Carisoprodol
( 4) Nalbuphine Hydrochloride
( 5) Butorphanol Tartrate
( 6) Dezocine
( 7) Dichloralphenazone
( 8) Zaleplon
( 9) Zolpidem
E. NARCOTIC DRUG: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation containing limited quantities of any of the following narcotic drugs or any salts thereof: Not more than 1 milligram of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.
F. EXEMPTION OF CHLORAL: When packaged in a sealed, oxygen- free environment, under nitrogen pressure, safeguarded against exposure to the air. Chloral when existing under the above conditions, is a substance which is not intended for general administration to a human being or another animal, and contains no narcotic controlled substances and is packaged in such a form that the package quantity does not present any significant potential for abuse. All persons who engage in industrial activities with respect to such chloral are subject to registration; but shall be exempt from Section 30- 31- 16 through 19 of the New Mexico Controlled Substances Act and 16.19.20.19 NMAC through 16.19.20.52 NMAC of the Board of Pharmacy regulations.
G. EXEMPT COMPOUNDS: Librax and Menrium are preparations which contain chlordiazepoxide, a depressant listed in Schedule IV, 16.19.20.68. A. 5 NMAC and other ingredients in such combinations, quantity, preparation or concentration as to vitiate the potential for abuse of chlordiazepoxide, and are hereby exempt preparations.
( 1) Librax
( 2) Menrium, 5- 2
( 3) Menrium, 4- 5
( 4) Menrium, 10- 4
[ 16.19.20.68 NMAC - Rp 16 NMAC 19.20.28( 3), 07- 15- 02; A, 06- 30- 05]
16.19.20.69 SCHEDULE V:
A. Narcotic drugs containing non- narcotic active medicinal ingredients. Any compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth below, which shall include one or more non- narcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by narcotic drugs alone.
( 1) Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams.
( 2) Not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams.
( 3) Not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100 grams.
( 4) Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit.
( 5) Not more than 100 milligrams of opium per 100 milliliters or per 100 grams.
( 6) Not more than 0.5 milligrams of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.
B. Stimulants. Unless specifically exempted or excluded or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers and salts of isomers.
( 1) Pyrovalerone.
27
( 2) Pseudoephedrine as a drug that includes any compound, mixture, or preparation that contains any detectable quantity of pseudoephedrine, its salts or its optical isomers, or salts of its optical isomers. Pursuant to 30- 31- 10. C the following substances are excluded from Schedule V controlled substances: pseudoephedrine products in liquid form including liquid filled gel caps and pseudoephedrine products already classified as dangerous drugs.
C. Depressants. Unless specifically exempted or excluded or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts:
( 1) Lacosamide [( R)- 2- acetoamido- N- benzyl- 3- methoxy- propionamide]
( 2) Pregabalin [( S)- 3-( aminomethyl)- 5- methylhexanoic acid]
[ 16.19.20.69 NMAC - Rp 16 NMAC 19.20.28( 4), 07- 15- 02; A, 06- 30- 05; A, 06- 30- 06; A, 01- 31- 07]
16.19.20.70 EXEMPT DANGEROUS DRUGS ( PRESCRIPTION STATUS DRUGS): The drugs set forth in the Federal DEA Table of Excepted Prescription Drugs published in a separate volume under Code of Federal Regulations, Title 21, Chapter II, Part 1308.32 have been exempt by the New Mexico Board of Pharmacy. Any deviation from the quantitative composition of any of the listed drugs shall require a petition for exemption to the Federal DEA in order that a drug may be exempt by DEA and the New Mexico Board of Pharmacy.
[ 16.19.20.70 NMAC - Rp 16 NMAC 19.20.28( 5), 07- 15- 02]
HM 72- Salvia Divinorum: Mr. Harvey discussed the reported abuse of this plant due to its hallucinogenic properties. He stated that there would be a foolow- up with poison control and that the DEA has put this on their watchlist.
Proposed Change to 16.19.6 NMAC and a New Rule for “ change of ownership” for any business licensed pursuant to 61- 11- 14: Mr. Harvey discussed proposed language regarding the definition of “ ownership” and how it relates to transfers and new ownership.
Pharmacy Fund Transfer for NMMIP: Mr. Harvey stated that the funds were transferred over to the prescriptive drug program.
Proposed Addition of Euthanasia Technicians to 16.19.20.8( D) NMAC: Mr. Harvey discussed the registration requirement for euthanasia technicians to acquire a controlled substance license.
Motion:
A motion was made by Mr. Nunley, seconded by Ms. Saavedra to notice 16.19.20.8( D) at the October 2009 board meeting. The board voted unanimously to pass the motion.
ACPE Request for Observer: Mr. Harvey stated that he will pick up the forms.
Drug Take- Back Laws and Rules: Mr. Harvey stated that although the first drug take- back program was very successful, it must meet the requirements of the EDA. Mr. Harvey stated that Senator King was in favor of statute and rule changes and that more discussions regarding proposed language for 16.19.6.15 NMAC will be discussed in September.
Motion:
A motion was made by Ms. Saavedra, seconded by Mr. Ortega to notice 16.19.6.15 NMAC at the October 2009 board meeting. The board voted unanimously to pass the motion.
Update on Counseling Requirement: Mr. Harvey wrote an article for the newsletter regarding this subject.
HM 121: Soniclear ** inaudible**
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Pharmacist Prescriptive Authority: Ms. Disco presented language regarding prescriptive authority and emergency contraception relating to 16.19.26.10 NMAC.
Private/ Clinic Practice: Discussion was held regarding the “ patient bill of rights” and possible models being discussed in the committee as per Joe Anderson.
RECONVENE TUESDAY AUGUST 25TH, 2009:
The Chairman reconvened at 9: 00 a. m. and took roll call. Present were Mr. Anderson, Mr. Shaver, Mr. Nunley, Mr. Mazzoni, Ms. Buesing and Mr. Cross. Mr. Cross stated that Mr. Carrier and Mr. Ortega are running late and that a quorum is present.
SETTLEMENT AGREEMENTS/ SURRENDERS/ DEFAULT ORDERS:
2009- 035: A settlement agreement was presented to the board for Amanda Valencia.
Motion:
A motion was made by Mr. Nunley, seconded by Mr. Anderson to accept the settlement agreement for Amanda Valencia. The board voted unanimously to pass the motion.
2009- 097: The voluntary surrender for Howard N. Schwartz was presented to the board.
Motion:
A motion was made by Mr. Mazzoni, seconded by Mr. Nunley to accept the voluntary surrender for Howard N. Schwartz. The board voted unanimously to pass the motion.
2009- 102: The voluntary surrender was presented to the board for Robyn Salazar.
Motion:
A motion was made by Mr. Shaver, seconded by Ms. Buesing to accept the voluntary surrender for Howard N. Schwartz. The board voted unanimously to pass the motion.
The chairman stated that Mr. Carrier and Mr. Ortega were present at 9: 08 a. m.
EXECUTIVE DIRECTOR’S REPORT:
Open Meetings Resolution Adoption: Mr. Harvey presented the current resolution to the board.
Motion:
A motion was made by Ms. Buesing, seconded by Mr. Shaver to approve the resolution as presented. The board voted unanimously to pass the motion.
Board Meeting Dates: The board discussed the board meeting dates for 2010. The dates will be as follows;
Motion:
A motion was made by Mr. Ortega, seconded by Mr. Anderson to approve the 2010 board meeting dates. The board voted unanimously to pass the motion.
January 11th – 12th, 2010
March 15th - 16th, 2010
June 14th – 15th, 2010
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30
August 30th – 31st, 2010 Ruidoso
October 18th – 19th, 2010
GENERAL BOARD DISCUSSION/ OPEN SESSION/ GOALS FOR 2010:
Mr. Harvey and the board discussed a variety of issues regarding private practice, clinics, and pharmacy practices. Machine dispensing of drugs, pooling drugs and remote dispensing in hospitals was discussed. FYI, no action taken.
Ms. Buesing discussed language to be used for “ PSA’s” regarding medication safety and counseling by pharmacist. FYI, no action taken.
Mr. Harvey and Ms. Mary Smith discussed the issues regarding the jurisdiction of the pharmacy board pertaining to the one pharmacy at Sandia Labs that dispenses medication to the employees. Currently the pharmacy board does not have jurisdiction at Sandia Labs. FYI, no action taken.
The Chairman asked for a 10- minute recess at 10: 15 a. m.
RECESS:
RECONVENE:
The board reconvened at 10: 25 a. m.
Executive Director’s Report Cont’d:
Election of Officers: The board discussed the nominations for officers.
Motion:
A motion was made by Mr. Ortega, seconded by Mr. Mazzoni to elect Mr. Danny Cross as Chairman, Mr. Allen Carrier as Secretary and Ms. Amy Buesing as Vice- Chairman. The board voted unanimously to pass the motion.
Case Presentations:
Motion:
A motion was made by Mr. Ortega, seconded by Ms. Buesing to go into closed session to discuss case presentations. A roll call vote was taken. Mr. Ortega, Ms. Buesing, Mr. Mazzoni, Ms. Buesing, Mr. Mazzoni, Mr. Carrier, Mr. Nunlry, Mr. Shaver and Mr. Anderson voted unanimously to pass the motion.
The board went back into open session and the only issue discussed was case presentation.
Motion:
A motion was made by Ms. Buesing, seconded by Mr. Anderson to close cases as follows; 2008- 046, 2009- 035, 2009- 043, 2009- 057, 2009- 071, 2009- 098, 2009- 099, 2009- 042, 2009- 068, 2009- 080, 2009- 090, 2009- 097, 2008- 119, 2009- 055, 2009- 074, 2009- 081, 2009- 098, 2009- 102 and send advisory letter t; 2009- 067, 2009- 079, 2009- 098 and send NCA’s to; 2009- 031, 2009- 070, 2009- 085, 2009- 093, 2009- 072, 2009- 082 and to leave open; 2009- 083, 2009- 036. The board voted unanimously to pass the motion.
Motion:
A motion was made by Mr. Anderson, seconded by Mr. Nunley to adjourn the meeting. The board voted unanimously to pass the motion.
The board meeting was adjourned at 12: 15 p. m.

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New Mexico Board of Pharmacy Regular Board Meeting
August 24th & 25th, 2009
Monday August 24th, 2009
PLACE AND TIME: The Meeting was held at the Ruidoso Convention Center, 111 Sierra Blanca Dr. Ruidoso, New Mexico.
CALL TO ORDER: The meeting was called to order by the Chairman Danny Cross,
R. Ph., at 9: 00 a. m.
MEMBERS PRESENT: Danny Cross, R. Ph., Chairman
Amy Buesing R. Ph., Member
Allen Carrier, Secretary
Thomas Ortega R. Ph., Member
Ray Nunley. Member
Richard Mazzoni, Member
Howard Shaver Public Member
Joe Anderson, Member
Buffie Saavedra, Public Member ( Monday August 24th only)
MEMBERS ABSENT: Buffie Saavedra, Public Member ( Tuesday August 25th only)
STAFF ATTENDING: Mary Smith, Assistant Attorney General
William Harvey, Executive Director
Debra Wilhite, Administrative Secretary
Maria Gonzales, Administrative Assistant
ROLL CALL:
Mr. Cross took roll call at 9: 05 a. m. Present were Mr. Ortega, Ms. Buesing, Ms. Saavedra, Mr. Mazzoni, Mr. Nunley, Mr. Shaver and Mr. Anderson. The Chairman stated that Mr. Carrier would be running late.
Mr . Harvey introduced the two new board members Mr. Ray Nunley and Mr. Richard Mazzoni.
Mr. Nunley stated that he wanted to give a thank you out to Long’s Pharmacy, Walgreens, and Wal- Mart for all the snacks and refreshments.
APPROVAL OF THE AGENDA:
The Chairman asked if there were any changes to the agenda. Mr. Harvey stated that there were two additions to the public requests letters “ m” pharmacists prescriptive authority and “ n” private/ clinic practice.
Motion:
A motion was made by Ms. Buesing, seconded by Mr. Shaver to approve the changes to the agenda. The board voted unanimously to pass the motion.
APPROVAL OF THE JUNE 15TH & 16TH, 2009 MEETING MINUTES:
The Chairman asked if there were any changes to the minutes. There were no changes to the minutes.
Motion:
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A motion was made by Mr. Ortega, seconded by Ms. Saavedra to approve minutes as presented. The Board voted unanimously to pass the motion.
COMMITTEE REPORTS:
Tele- pharmacy Committee: Ms. Saavedra discussed the new rule 16.19.33 NMAC with the board regarding any comments.
Motion:
A motion was made by Mr. Ortega, seconded by Ms. Saavedra to notice 16.19.33 NMAC at the October 2009 board meeting. The board voted unanimously to pass the motion.
TITLE 16 OCCUPATIONAL AND PROFESSIONAL LICENSING
CHAPTER 19 PHARMACISTS
PART 33 TELE- PHARMACY AND REMOTE DISPENSING
16.19.33.1 ISSUING AGENCY: Regulation and Licensing Department - Board of Pharmacy.
16.19.33.2
SCOPE: This section applies to hub pharmacies and remote tele- pharmacies. Both the hub pharmacy and all remote tele- pharmacies must be located within New Mexico. The remote tele- pharmacy must be greater than 25 miles from an existing community pharmacy to qualify under these rules.
16.19.33.3 STATUTORY AUTHORITY: Section 61- 11- 6( A)( 6) NMSA 1978 requires that the Board of Pharmacy provide for the licensing of retail pharmacies and nonresident pharmacies and for the inspection of their facilities and activities. Section 61- 11- 6( A)( 1) NMSA 1978 requires the Board of Pharmacy to adopt, amend or repeal rules and regulations necessary to carry out the provisions of the Pharmacy Act.
16.19.33.4 DURATION: Permanent
16.19.33.5 EFFECTIVE DATE: ( Set date), unless a later date is cited at the end of a section.
16.19.33.6 OBJECTIVE: The objective of Part 33 of Chapter 19 is to ensure the safe and competent delivery of quality pharmaceutical products and the provision of pharmaceutical care to the public by establishing standards for the operation of remote dispensing sites and tele- pharmacy, including but not limited to minimum space requirements and standards for equipment, accessories, personnel, dispensing, labeling.
16.19.33.7 PURPOSE: The Board of Pharmacy is responsible for maintaining, continuing and enhancing the development of the education and professional role of the pharmacist for the protection of the health, welfare and safety of the citizens of New Mexico. New Mexico is facing a pharmacy services accessibility problem due to the closing of pharmacies and the lack of registered pharmacists. In order to maintain or
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make pharmacy services available in communities that have no licensed pharmacy or are in jeopardy of losing their licensed pharmacy, rules are necessary to permit remote tele- pharmacy services and remote dispensing.
16.19.33.8
DEFINITIONS:
A.
“ Average Number of Prescriptions Filled per Day ( ANPFD) means the total number of prescriptions filled during a calendar month divided by the total number of days open that month.
B. “ Electronic Link” means a real time, continuous computer, video and audio link between the hub pharmacy and the remote tele- pharmacy during all hours of operation and in compliance with 16.19.33.9A( 4).
C. “ Continuous video supervision” means a constant live video link with not less than 4 camera views which allows for real time live monitoring of the remote Tele- pharmacy remote dispensing site which is recorded for a minimum of 180 days.
D. “ Patient- Pharmacist Audio Visual Link” means a real time audio visual link from the private patient counseling area of the remote tele- pharmacy to the pharmacist at the hub pharmacy
E.
“ Hub Pharmacy” means a New Mexico licensed pharmacy operating under the direct control of a pharmacist from which computer- aided pharmacist supervision of a remote tele- pharmacy occurs.
F. “ Hub Pharmacist” means a New Mexico registered pharmacist who oversees the day to day operations of a remote tele- pharmacy via an electronic link that includes provisions for visual observations and inspection of the inside of the pharmacy and all prescription orders prior to dispensing. This oversight to include visual inspection of and patient consultation for any prescription order dispensed from the remote tele- pharmacy.
G.. “ Pharmacist- in- Charge” means the pharmacist- in- charge for the hub pharmacy from which the hub pharmacist oversees the day- to- day operation of a remote tele- pharmacy and who shall comply with 16 NMAC 19.6.9.
H.. “ Pharmacist site visits”: defines how often a pharmacist must physically visit the
remote tele- pharmacy.
- at least once a month when the ANPFD is 1 to 50,
- at least once every two weeks when the ANPFD is 51 to 100 per day,
- at least once per week when the ANPFD is 101 to 150,
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- at least twice per week when the ANPFD is 151 to 200.
- a pharmacist is required on site full time during normal operating hours
if the ANPFD exceeds 200.
I. “ Remote Dispensing Site” means a pharmacy location primarily staffed by technicians and remote dispensing technology “ Electronic Link” and continuous video supervision with required supervision and in person visits from the hub pharmacy pharmacist.
J. “ Remote Tele- Pharmacy” means a licensed pharmacy located in the State of New Mexico staffed by a remote tele- pharmacy technician who practices under the direct, computer aided, and supervision of a hub pharmacist working from the hub pharmacy by electronic link during all hours of operation.
K. “ Remote Tele- Pharmacy Technician” means a New Mexico registered pharmacy technician, employed by the hub pharmacy, with a minimum of two- thousand hours of experience working, as a certified registered pharmacy technician who, under the computer aided supervision of an off- site pharmacist, handles the day to day operation of a remote tele- pharmacy, including the preparation and dispensing of prescription drugs.
L. “ Practice of Tele- pharmacy” means the provision of pharmacist care by registered pharmacies and pharmacists through the use of telecommunications or other technologies to patients or their agents at a remote site.
16.19.33.9 OPERATIONS
A.
A remote tele- pharmacy shall comply with all sections of NMAC 16.19.6.8 governing the procedure for obtaining a license to operate a pharmacy in New Mexico:
( 1)
The license holder of the hub pharmacy must apply for a license to operate a remote tele- pharmacy. A remote tele- pharmacy license is established for the purpose of conducting a remote tele- pharmacy. The license is issued to a remote tele- pharmacy connected to a hub pharmacy via an electronic link. The initial licensure fee and subsequent license renewal fee are the same as those for retail pharmacies, as required by 16NMAC 19.12.13E.
( 2)
A remote tele- pharmacy that operates under different ownership than the hub pharmacy; to which it is attached; shall have a written
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a.
The applicant must provide sufficient evidence that the proposed location is in an area of the State lacking access to a retail pharmacy. The Board will utilize the evidence supplied by the applicant and from other sources when making a determination that sufficient evidence exists to approve an application for a remote tele- pharmacy.
( 3)
A remote tele- pharmacy shall comply with all the applicable requirements for a pharmacy as contained in NMAC 16.19 Part 6. Pharmacies.
( 4)
A remote tele- pharmacy shall be connected to a hub pharmacy via an electronic link. All links must be fully operational during all hours of operation of the remote tele- pharmacy. If any link malfunctions, the remote tele- pharmacy must be closed unless a pharmacist is physically present at the remote pharmacy site.
a.
Video equipment must be capable of providing an adequate number of simultaneous views of the pharmacy operation at the remote tele- pharmacy.
b.
The video equipment at the remote tele- pharmacy site must be capable of resolution sufficient to allow for pharmacist identification of medication dosage forms and the reading of bottle labels via video camera.
c.
The video link between a hub pharmacy and a remote tele- pharmacy site must be capable of recording and maintaining at least one hundred eighty ( 180) days of video surveillance of the remote tele- pharmacy site and operations for future review.
d.
Only a remote tele- pharmacy technician designated for that site or a pharmacist who is physically present at the remote tele- pharmacy may access a remote tele- pharmacy site, linked to a hub pharmacy via an electronic link.
e.
The remote tele- pharmacy may only remain open as long as the designated pharmacy technician is present in the remote tele- pharmacy and the hub pharmacist is present at the hub pharmacy or at the remote site.
f.
The name of each certified pharmacy technician that works at a remote tele- pharmacy shall be recorded with the New Mexico Board of Pharmacy. Notification of any change of staff at a remote tele- pharmacy shall be made to the Board of Pharmacy immediately. 5
( 5)
The pharmacist in charge of the hub pharmacy shall produce a policy and procedure for the safe and effective operation of the remote tele- pharmacy and the oversight by the hub pharmacy. This manual shall be available for Board inspection in both the remote tele- pharmacy and the hub pharmacy. The policy and procedure manual shall be reviewed by the pharmacist- in- charge annually and revised if necessary to promote improvements in safety and service at the remote tele- pharmacy. The annual review and any changes to the manual shall be documented.
( 6)
The pharmacist- in- charge is responsible for an ongoing review of incident reports and outcomes, with appropriate corrective action taken.
( 7)
A pharmacist employed by the hub pharmacy must visit and complete inspections of the remote tele- pharmacy according to the visitation requirements of 16.19.33.8. H. A list of inspection criteria shall be included in the policy and procedure manual for the remote tele- pharmacy. The pharmacist’s inspection shall include a determination of the average number of prescriptions filled per day. A copy of the inspection report shall be reviewed and signed by the pharmacist- in- charge of the hub pharmacy and a copy of the inspection report shall be maintained at both the remote tele- pharmacy and at the hub pharmacy for Board of Pharmacy inspection.
( 8)
The number of pharmacy technicians that a hub pharmacist may oversee shall be limited according to NMAC 16.19.22.10. Any pharmacy technicians on duty at the hub pharmacy site shall be taken into account along with any remote tele- pharmacy technicians working at remote tele- pharmacy sites, when computing the ratio of pharmacists to pharmacy technicians. Application for an increase in the ratio of pharmacy technicians to pharmacists may be made in accordance with NMAC 16.19.22.10B.
( 9)
A remote tele- pharmacy may have a dangerous drug inventory. Any controlled substances shall be kept at the remote site in accordance with NMAC 16.19.20.
a.
If controlled substances are kept, the remote tele- pharmacy shall be registered with the Drug Enforcement Administration and obtain its own DEA number.
b.
If controlled substances are kept, the remote tele- pharmacy shall have a valid New Mexico Controlled Substance Registration as required in NMAC 16.19.20.
c.
All controlled substances kept in inventory by the remote tele- pharmacy shall be listed on a perpetual inventory log, which shall be updated upon the dispensing of each controlled substance prescription or other disposition.
d.
The pharmacist shall perform monthly audits of all controlled substances during regular inspection visits to the remote tele- pharmacy. 6
( 10)
Prescriptions may be received, entered and filled or re- filled by the hub pharmacy and sent to the remote tele- pharmacy for distribution to the patient during hours when the technician is present in the remote tele- pharmacy. A pharmacist at the hub pharmacy must approve each prescription before it leaves the remote tele- pharmacy site.
a.
The pharmacist’s initials and the technician’s initials shall be recorded.
b.
The pharmacist shall compare the stock bottle, the drug dispensed, and drug strength. The entire prescription label must be checked for accuracy. All prescriptions distributed by the remote tele- pharmacy must have the label affixed to the prescription container prior to being inspected by the pharmacist via electronic link.
( 11)
Patient counseling shall be done by a pharmacist via an electronic link. The pharmacist shall counsel the patient or the patient’s agent on all new prescriptions and refills. All counseling, according to 16NMAC19.4.16E, remains the responsibility of the pharmacist at the hub pharmacy via an electronic link.
The chairman stated that Mr. Carrier was present at 10: 08 a. m.
APPLICATIONS:
Application List:
Clinic:
Mr. Carrier stated that there are 9 applications in this category and all are in order.
Motion:
A motion was made by Mr. Carrier, seconded by Mr. Ortega to approve all 9 applications in this category as presented. The board voted unanimously to pass the motion.
Animal Control:
Mr. Carrier stated that there is one application in this category and is in order.
Motion:
A motion was made by Mr. Carrier, seconded by Ms. Saavedra to approve the one application in this category as presented. The board voted unanimously to pass the motion. Mr. Ortega abstained from the vote.
Home Healthcare:
Mr. Carrier stated that there is one application in this category and is in order.
Motion:
A motion was made by Mr. Carrier, seconded by Ms. Buesing to approve the one application in this category as presented. The board voted unanimously to pass the motion. 7
Limited Drug Researcher:
Mr. Carrier stated that there is one application in this category and is in order.
Motion:
A motion was made by Mr. Carrier, seconded by Mr. Ortega to table the one application in this category as presented until the licensing manager Sarah Trujillo was contacted to clarify the schedules listed for this license. The board voted unanimously to pass the motion.
Motion:
A motion was made by Mr. Carrier, seconded by Mr. Ortega to approve the one application in this category after speaking with Ms. Trujillo and clarifying the schedules for this application are 1, 2, and 2N. The board voted unanimously to pass the motion.
Emergency Medical Services:
Mr. Carrier stated that there is one application in this category and is in order.
Motion:
A motion was made by Mr. Carrier, seconded by Ms. Buesing to approve the one application in this category as presented. The board voted unanimously to pass the motion.
Custodial/ Nursing Home:
Mr. Carrier stated that there are 14 applications in this category and all are in order.
Motion:
A motion was made by Mr. Carrier, seconded by Mr. Shaver to approve the 14 applications in this category as presented. The board voted unanimously to pass the motion.
Hospital:
Mr. Carrier stated that there are 3 applications in this category and all are in order.
Motion:
A motion was made by Mr. Carrier, seconded by Mr. Nunley to approve the 3 applications in this category as presented. The board voted unanimously to pass the motion.
Pharmacy:
Mr. Carrier stated that there are 7 applications in this category and all are in order.
Motion:
A motion was made by Mr. Carrier, seconded by Mr. Ortega to approve the 7 applications in this category as presented. The board voted unanimously to pass the motion. Mr. Nunley abstained from the vote.
Non- Resident Pharmacy:
Mr. Carrier stated that there are 9 applications in this category and all are in order.
8
Motion:
A motion was made by Mr. Carrier, seconded by Ms. Buesing to approve the 9 applications in this category as presented. The board voted unanimously to pass the motion.
Wholesaler/ Broker:
Mr. Carrier stated that there are 14 applications in this category and all are in order.
Motion:
A motion was made by Mr. Carrier, seconded by Mr. Ortega to approve the 14 applications in this category as presented and to strike the addresses on # 6, # 7, # 8, # 9 due to security issues. The board voted unanimously to pass the motion.
Pharmacist Credentialing Committee:
Mr. Carrier presented 6 applications that were discussed by the committee on August 13th and 18thth, 2009. The applications were for Carol Bailor, Deborah Carabello, Olivier Waiman, Louanne Cunico, Larry Georgeopoulos, and Quentin Florence.
Motion:
A motion was made by Mr. Carrier, seconded by Ms. Saavedra to approve the recommendations for pharmacist clinician by the credentialing committee for Deborah Caraballo, Olivier Waiman, Louanne Cunico, Larry Georgeopoulos and Quentin Florence and that the recommendations for Ms. Bailar must be completed within the next six months first before the board will consider the waiver request made by her to the board. The board voted unanimously to pass the motion.
Motion:
A motion was made by Ms. Buesing, seconded by Mr. Anderson to note that Mr. Ortega abstained from the vote. The board voted unanimously to pass the motion. For Carol Bailar
Motion:
A motion was made Mr. Carrier, seconded by Ms. Saavedra to approve the recommendations for prescriptive authority by the credentialing committee for Deborah Caraballo, Olivier Waiman and to table Quentin Waiman until his updated protocol including QA program of practice has been received. The board voted unanimously to pass the motion.
Motion:
A motion was made by Mr. Carrier, seconded by Ms. Buesing to attach the lists to the minutes. The board voted unanimously to pass the motion.
NEW MEXICO BOARD OF PHARMACY
REGULAR MEETING
APPLICATION LIST
August 24 & 25, 2009
9
CLINIC CONSULTANT PHARMACIST
1. Albuquerque Health Services- NE Clinic Change of Ownership
112 Monroe Street NE Candice Morrow, R. Ph.
Albuquerque, NM 87108
2. Albuquerque Health Services- NW Clinic New
172 Montano NW Candice Morrow, R. Ph.
Albuquerque, NM 87120
3. Fresenius Medical Care Rio Rancho Relocation
1760 Grande Blvd # 100 Wilfred Chavez, R. Ph.
Rio Rancho, NM 87124
4. Fresenius Medical Care Gibson Change of Ownership
5400 Gibson SE # 100 1st Floor Wilfred Chavez, R. Ph.
Albuquerque, NM 87108
5. LCMC Surgical Clinic New
205 Sudderth Drive Deborah Christopherson, R. Ph.
Ruidoso, NM 88345
6. Planned Parenthood of New Mexico Relocation
730 St Michael’s Drive Suite 4B Constance Hyde, R. Ph.
Santa Fe, NM 87505
7. Southeast Height Center for Family Health Relocation
8200 Central Avenue Anita Sanchez, R. Ph.
Albuquerque, NM 87108
8. UNM Hospitals Adult Infusion New
1201 Camino de Salud NE Stanley Cheshire, R. Ph.
Albuquerque, NM 87106
9. WNMMG- Grants Relocation
1217 Bonita Charles Vandiver, R. Ph.
Grants, NM 87020
ANIMAL CONTROL CONSULTANT PHARMACIST
1. Grants Police Department Relocation
722 Sakelares Blvd Phil Parkhurst, R. Ph.
Grants, NM 87020
HOME HEALTHCARE CONSULTANT PHARMACIST
1. University Home Care and Hospice Relocation
933 Bradbury Suite 3082 Cynthia Lujan, R. Ph.
Albuquerque, NM 87106
10
LIMITED DRUG RESEARCHER
1. Taos Police Department New
107 Civic Plaza Drive
Taos, NM 87571
EMERGENCY MEDICAL SERVICES CONSULTANT PHARMACIST
2. Rio Arriba County EMS New
1122 Industrial Park Road Christina Atwell, R. Ph.
Espanola, NM 87532
CUSTODIAL/ NURSING HOME CONSULTANT PHARMACIST
1. Active Solutions Inc New
10300 Lawton Street NW Annabel Roberts, R. Ph.
Albuquerque, NM 87114
2. Campo Behavioral Health New
424 N Mesilla Street R H Rede, R. Ph.
Las Cruces, NM 88005
3. Campo Behavioral Health New
2075 Enzie R H Rede, R. Ph.
Las Cruces, NM 88005
4. Campo Behavioral Health New
1812 Augustus R H Rede, R. Ph.
Las Cruces, NM 88005
5. Caring House New
1024 Marapi NW Evangeline Ward, R. Ph.
Albuquerque, NM 87120
6. Casa Fina Assisted Living LLC New
11921 Euclid Court NE Reynaldo Saenz, R. Ph.
Albuquerque, NM 87112
7. Cuidando Las Familias Inc New
7116 Cuchillo Road NW Reynaldo Saenz, R. Ph.
Albuquerque, NM 87114
8. Cuidando Las Familias Inc New
# 10 Rosalia Road Reynaldo Saenz, R. Ph.
Cedar Crest, NM 87008
9. Helen Castro New
403 Arrow Road Rudy Nolasco, R. Ph.
Las Vegas, NM 87701
11
10. Lorencita Lopez New
42 Crawford Road Wilfred Chavez, R. Ph.
Jarales, NM 87023
11. Opti- Health New
3513 Pitt Avenue Perry Storey, R. Ph.
Albuquerque, NM 87111
12. Ramah Care Services New
1500 South 2nd Street Suite 1 Perry Storey, R. Ph.
Gallup, NM 87301
13. Silver Lining Services LLC New
1447 East Roosevelt Cyndi Reynolds, R. Ph.
Grants, NM 87020
14. Silver Lining Services LLC New
1015 Sage Cyndi Reynolds, R. Ph.
Grants, NM 87020
HOSPITAL PHARMACIST IN CHARGE
1. BHC Mesilla Valley Hospital Pharmacy Remodel
3521 Del Rey Blvd Pamela Brummal, R. Ph.
Las Cruces, NM 88012
2. Lovelace Medical Center Inpatient Pharmacy Relocation
601 Dr Martin Luther King Jr Kurt Mahan, R. Ph.
Albuquerque, NM 87102
3. Lovelace Medical Towers Outpatient Pharmacy Remodel
500 Walter Street Suite 202 Sam Sanchez, R. Ph.
Albuquerque, NM 87102
PHARMACY PHARMACIST IN CHARGE
1. K & M Lab and Pharmacy Relocation
5740 Night Whisper NW Connie Tsui, R. Ph.
Albuquerque, NM 87114
2. Total Health & Wellness Center of Taos New
622B Paseo del Pueblo Sur Jake Mossman, R. Ph.
Taos, NM 87571
3. UNMH Refill Center Relocation
1130 University NE Suite G Margaret Gallegos, R. Ph.
Albuquerque, NM 87102
4. Walgreens New 12
3990 East Lohman Avenue Mateo Delgado, R. Ph.
Las Cruces, NM 88011
5. Wal* Mart Remodel
01 I- 25 Interchange Theresa Sanchez, R. Ph.
Belen, NM 87002
6. Wal* Mart Remodel
1800 West Hwy 70 Carilyn Miller, R. Ph.
Ruidoso Downs, NM 88346
7. Wal* Mart Remodel
2330 S New York Avenue Debra Dunn, R. Ph.
Alamogordo, NM 88310
NON- RESIDENT PHARMACY PHARMACIST IN CHARGE
1. Allied Preferred New
8625 King George Drive # 300 Tommy Swayden, R. Ph.
Dallas, TX 75235
2. Commcare Pharmacy New
2817 E Oakland Park Blvd # 303 Sal Saraniti, R. Ph.
Fort Lauderdale, FL 33306- 1889
3. Costco Wholesale Corporation New
215 Deininger Circle Yong Lee, R. Ph.
Corona, CA 92880
4. Long Beach Prescription Pharmacy New
2632 Pacific Avenue Toan Thai, R. Ph.
Long Beach, CA 90806
5. Omnicare of Texas 1 LP New
DBA Omnicare of Fort Worth John Gray, R. Ph.
14450 Trinity Blvd Suite 200
Fort Worth, TX 76155
6. One Stop Pharmacy New
3193 Tech Drive Suite B Randolph Breton, R. Ph.
St Petersburg, FL 33716
7. Option Care Enterprises Inc New
10924 John Galt Blvd Erica Garris, R. Ph.
Omaha, NE 68137
8. PVPL New
10077 South 134th Street Jennifer O’Grady, R. Ph.
Omaha, NE 68138
13
WHOLESALE/ BROKER
1. Abbott Laboratories Inc New
8901 Forney Road
Dallas, TX 75227
2. Comp Ray Inc New
4801 Ellison Street NE Suite J
Albuquerque, NM 87109
3. Correct Rx Pharmacy Services Inc New
803- A Barkwood Court
Linthicum, MD 21090
4. De Royal Industries Inc New
1755 HWY 33 South
New Tazewell, TN 37825
5. Diplomat Specialty Pharmacy New
2029 S Elms Road Suite G
Swartz Creek, MI 48473
6. McKesson Specialty Distribution LLC New
7. McKesson Specialty Distribution LLC New
8. McKesson Specialty Distribution LLC New
9. McKesson Specialty Distribution LLC New
10. Promotech Logistics Solutions LLC New
DBA Promotech
25 Madison Road
Totowa, NJ 07512
11. RIT Oncology LLC New
1700 Seventh Avenue Suite 2100
Seattle, WA 98101
12. Teva Women’s Health Inc New
5040 Duramed Drive
Cincinnati, OH 45213
13. United Therapeutics Corporation New
55 T W Alexander Drive
Research Triangle Park, NC 27709
14. X- Gen Pharmaceuticals Inc New
300 Daniel Zenker Drive
Horseheads, NY 14845 14
The Chairman asked for a 10- minute recess at 10: 40 a. m.
RECESS:
RECONVENE:
The board reconvened at 10: 50 a. m.
Committee Reports Cont’d:
Pharmacist Clinician Committee: Mr. D” Amour addressed issues regarding Ms. Bailar’s waiver request during approval of applications for pharmacist clinician.
Pharmacist CE Committee: Mr. Anderson stated that he and Ms. Saavedra would be sending out surveys to all licensed pharmacist to capture their input on requirements of education and the availability of types of CE’s, by November 1st, 2009, of which they will compile the information returned and inform the board when completed He also stated that the committee had voted yes to live CE being offered and that the number of hours and types were still being discussed but at least a 30 hour requirement with initial licensure. Mr. Ortega mentioned that CE on medication errors should be considered. Ms. Disco discussed “ continuous professional development” and the need for it during the licensing period.
RULE HEARING – 16.19.6 NMAC:
Mr. Harvey presented the amended language to the board from Mr. Sauceda for comment. The board and Mr. Saucedo discussed the amended changes regarding Section 11 of 16.19.6 NMAC. Mr. Harvey added the changes as requested by the board.
Motion:
A motion was made by Mr. Ortega, seconded by Ms. Buesing to approve the rule 16.19.6 NMAC as amended. The chairman took a roll call vote. Mr. Ortega, Ms. Saavedra, Ms. Buesing, Mr. Mazzoni, Mr. Carrier, Mr. Nunley, Mr. Shaver, Mr. Anderson, and Mr. Cross all voted unanimously to pass the motion. The Chairman asked that the notice be marked as exhibit # 1, amendment to the rule be marked as exhibit # 2, and the letter from Phil Saucedo be marked as exhibit # 3.
( 2) Requirements for training.
a.
All pharmacists prior to compounding sterile pharmaceuticals, or supervising pharmacy personnel compounding sterile pharmaceuticals, all shall have completed a minimum of 20 contact hours of didactic, experiential training and competency evaluation through demonstration and testing ( written or practical) as outlined by the pharmacist- in- charge and described in the policy and procedures or training manual. Such training shall be evidenced by completion of a recognized course in an accredited college of pharmacy or an ACPE approved course which shall include instruction and hands- on experience in the following areas:
i.
aseptic technique;
ii.
critical area contamination factors;
iii.
environmental monitoring;
iv.
facilities; 15
v.
equipment and supplies;
vi.
sterile pharmaceutical calculations and terminology;
vii.
sterile pharmaceutical compounding documentation;
viii.
quality assurance procedures;
ix.
proper gowning and gloving technique;
x.
the handling of cytotoxic and hazardous drugs; and
xi.
general conduct in the controlled area.
b.
All pharmacist interns prior to compounding sterile pharmaceuticals shall have completed a minimum of 40 hours of instruction and experience in the areas listed in paragraph 12. Such training will be obtained through the:
i.
completion of a structured on- the- job didactic and experiential training program at this pharmacy ( not transferable to another pharmacy); or
ii.
completion of a course sponsored by an ACPE approved provider.
iii.
certification by University of New Mexico College of Pharmacy upon graduation.
c.
All pharmacy technicians who compound sterile pharmaceuticals shall have a high school or equivalent education and be a certified pharmacy technician, and complete a minimum of 40 hours of instruction and experience in the areas listed in paragraph 12. Such training will be obtained through the:
i.
completion of a structured on- the- job didactic and experiential training program at this pharmacy ( not transferable to another pharmacy) which provides 40 hours of instruction and experience in the areas listed in paragraph 12; or
ii.
completion of a course sponsored by an ACPE approved provider which provides 40 hours of instructions and experience in the areas listed in paragraph 12.
d.
All pharmacists compounding sterile chemotherapy drugs or supervising pharmacy interns or technicians compounding sterile chemotherapy drugs shall, effective December 31, 2008, have completed a board approved training program in chemotherapy drug preparation. All pharmacy interns and technicians must complete this training prior to preparing sterile chemotherapy drug products.
Committee Reports Cont’d:
Pharmacy Technician Committee: No report at this time.
Emergency Preparedness Committee: ** partially inaudible** The board had a lengthy discussion regarding the declaration for emergency preparedness and DOH protocol. Mr. Harvey stated that the Pharmacy Act authorizes the executive director of the board of pharmacy to make decisions and carry out what may be deemed necessary to effectively provide for emergency situations.
Motion:
16
A motion was made by Mr. Ortega, seconded by Ms. Buesing to accept the declaration with suggested changes and protocol as presented. The board voted unanimously to pass the motion.
The chairman asked to recess for lunch at 12: 00 noon.
RECESS FOR LUNCH:
RECONVENE:
The board reconvened at 1: 35 p. m.
PUBLIC REQUESTS:
Artesia General Hospital Waiver Request: Mr. Irby was present to discuss the waiver request with the board. The board had issues regarding the seriousness of the director of the hospital not attending as requested. The board informed Mr. Irby that they would approve the waiver only until March 2010 and expect to have representatives for the hospital, attend the March meeting.
Motion:
A motion was made by Ms. Saavedra, seconded by Mr. Nunley to approve the waiver until March 2010. The board voted unanimously to pass the motion.
Gila Hospital: Mr. Ray Goellner was present to discuss the waiver request as stated in 16.19.6 NMAC for training. After a brief discussion the board agreed to accept the waiver as presented.
Motion:
A motion was made by Ms. Saavedra, Seconded by Mr. Shaver to approve the waiver request. The board voted unanimously to pass the motion.
Aloun Mary Vilay, Pharm D – Two Waiver Requests: Mr. Harvey presented the documentation provided by Ms. Vilay regarding her waiver request based on her BS in pharmacy from the University of Alberta as well as a Doctor of Pharmacy degree from the University of Toronto including fellowship training from the University of Michigan.
Motion:
A motion was made by Ms. Saavedra, seconded by Mr. Mazzoni to approve the request of exemption from obtaining the FPGEC certification for Ms. Aloun Mary Vilay. The board voted unanimously to pass the motion. Mr. Anderson and Ms. Buesing abstained from the vote.
Motion:
A motion was made by Ms. Saavedra, seconded by Mr. Shaver to accept the intern hours as presented by Ms. Vilay as requested in the waiver. The board voted unanimously to pass the motion.
Doug Scribner – CNM IV Training for Techs: Mr. Scribner was not present. Mr. Harvey presented documentation for the waiver request regarding the sterile products training issues. After a brief discussion the board agreed to approve the request for waiver.
Motion:
A motion was made by Mr. Nunley, seconded by Mr. Shaver to approve the waiver request for sterile products training as presented via documentation by Mr. Doug Scribner. The board voted unanimously to pass the motion.
17
Sarah Garnoke, PMI – Request for Waiver: Ms. Gamoke requested that the board allow the PIMA Director to sign off on the training records for pharmacy technician students therefore requesting a waiver on the PIC signing the training record.
Motion:
A motion was made by Mr. Shaver, seconded by Ms. Buesing to approve the waiver for two years. The board voted unanimously to pass the motion.
Phil Saucedo, Executive Director NMSHP, Rule Change Request 16.19.6.11( C) 2: Mr. Saucedo presented the amended language for 16.19.6.11( C) 2) regarding the certification requirements.
Motion:
A motion was made by Ms. Buesing, seconded by Mr. Ortega to notice the amended language for 16.19.6.11( C) 2 at the October 2009 board meeting. The board voted unanimously to pass the motion.
Committee Reports Cont’d:
BOP/ Chiropractic Formulary Committee - HB 14 Formulary Effective 9/ 11/ 09: A lengthy discussion was held regarding the validity of the formulary that has been presented for filing without the approval of the board of pharmacy based on statute 61- 1- 31( A) and 61- 1- 31( B) which gives the pharmacy board the standing to challenge the filing. Because the formulary was not presented to the board and due to the nature of drugs listed and the lack of information regarding their uses, indications and listing classes of drugs as apposed to listing the names of dangerous drugs, controlled substances, vitamins and minerals, and OTC drugs, the board will contact the chiropractic board for feedback. Ms Smith stated that the pharmacy board should look into when the rule was filed, get the transcript of the noticed rule and if the board feels they should pursue the issue to file with the court of appeals. Mr. Harvey also stated that he feels that the board should inform RLD. Ms. Smith stated that she will consult with her colleagues for further direction.
Motion:
A motion was made by Mr. Shaver, seconded by Mr. Mazzoni for the board to pursue the validity of the formulary as presented by the chiropractic board due to the lack of approval by the pharmacy board before the filing of the rule referenced as being effective 9/ 11/ 09. The board voted unanimously to pass the motion.
BOP/ BAOM Education Committee – BAOM Formulary; Letter from Chairman Pieper concerning new injections- approval of education requirements: Chairman Pieper briefly discussed education requirements and concerns regarding injections. No committee report at this time as per Mr. Cross.
The chairman asked for a 10- minute break at 2: 35 p. m.
RECESS:
RECONVENE:
The board reconvened at 2: 45 p. m.
Executive Director’s Report Cont’d:
Proposed Changes/ Additions to Controlled Substances Schedule I, II, III, IV, V: Mr. Harvey presented the proposed additions of controlled substances to 16.19.20 NMAC for a final approval.
Motion:
18
A motion was made by Mr. Carrier, seconded by Ms. Saavedra to notice 16.19.20 NMAC at the October 2009 board meeting. The board voted unanimously to pass the motion.
16.19.20.65 SCHEDULE I:
A. NMSA 1978 Section 30- 31- 6 schedule I shall consist of the following drugs and other substances, by whatever name, common or usual name, chemical name or brand name designated, listed in this section; OPIATES, unless specifically exempt or unless listed in another schedule, any of the following opiates, including its’ isomers, esters, ethers, salts and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation.
( 1) Acetylmethadol
( 2) Allyl prodine
( 3) Alphacetylmethadol
( 4) Alphameprodine
( 5) Alphamethadol
( 6) Alpha- methyl fentanyl
( 7) Benzethidine
( 8) Betacetylmethadol
( 9) Betameprodine
( 10) Betamethadol
( 11) Betaprodine
( 12) Clonitazene
( 13) Dextromoramide
( 14) Diampromide
( 15) Diethylthiambutene
( 16) Dimethylthiambutene
( 17) Difenoxin
( 18) Dimenoxadol
( 19) Dimepheptanol
( 20) Dimethylthiambutene
( 21) Dioxaphetyl Butyrate
( 22) Dipipanone
( 23) Ethylmethylthiambutene
( 24) Etonitazene
( 25) Etoxeridine
( 26) Furethidine
( 27) Hydroxypethidine
( 28) Ketobemidone
( 29) Levomoramide
( 30) Levophenacylmorphan
( 31) Morpheridine
( 32) Noracymethadol
( 33) Norlevorphanol
( 34) Normethadone
( 35) Norpipanone
( 36) Phenadoxone
( 37) Phenampromide
( 38) Phenomorphan
( 39) Phenoperidine
( 40) Piritramide
( 41) Proheptazine
( 42) Properidine
( 43) Propiram
( 44) Racemoramide
( 45) Tilidine
( 46) Trimeperidine
19
B. OPIUM DERIVATIVES: Unless specifically exempt or unless listed in another schedule, any of the following opium derivatives, its’ salts, isomers, and salts of isomers whenever the existence of such salts, isomers and salts of isomers is possible within the specific chemical designation.
( 1) Acetorphine
( 2) Acetyl dihydrocodeine
( 3) Benzyl morphine
( 4) Codeine methylbromide
( 5) Codeine- N- Oxide
( 6) Cyprenorphine
( 7) Desomorphine
( 8) Dehydro morphine
( 9) Etorphine
( 10) Heroin
( 11) Hydromorphinol
( 12) Methyldesorphine
( 13) Methyldihydromorphine
( 14) Morphine methylbromide
( 15) Morphine methylsulfonate
( 16) Morphine- N- Oxide
( 17) Myrophine
( 18) Nicocodeine
( 19) Nicomorphine
( 20) Normorphine
( 21) Pholcodine
( 22) Thebacon
( 23) Drotebanol
( 24) Beta- Hydroxy- 3- Methylfentanyl
( 25) 3- Methylthiofentanyl
( 26) Acetyl- Alpha- Methyl fentanyl
( 27) Alpha- Methylthiofentanyl
( 28) Beta- hydroxfentanyl
( 29) Para- Fluoro fentanyl
( 30) Thiofentanyl
C. HALLUCINOGENIC SUBSTANCES: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation, which contains any quantity of the following hallucinogenic substances, or which contains any of its’ salts, isomers, and salts of isomers whenever the existence of such salts, isomers and salts of isomers is possible within the specific chemical designation ( for purpose of this sub- section only, the term “ isomers” includes the optical position, and geometric isomers).
( 1) 3,4 - methylenedioxy amphetamine
( 2) 5 - methoxy - 3,4- methylenedioxy amphetamine
( 3) 3,4,5 - trimethoxy amphetamine
( 4) Bufotenine
( 5) Diethyltryptamine; DET
( 6) Dimethyltryptamine; DMT
( 7) 4- methyl- 2,5- dimethoxy- amphetamine; DOM or STP
( 8) Lysergic acid diethylamide
( 9) Lysergic acid diethylamide
( 10) Marijuana
( 11) Mescaline
( 12) Peyote
( 13) N- ethyl- 3- piperidyl benzilate
( 14) N- methyl- 3- piperidyl benzilate
( 15) Psilocybin
( 16) Psilocyn
( 17) Tetrahydrocannabinols 20
( 18) Parahexyl ( synthetic analog of delta- 9- tetrahydrocannabinol ( THC) an active ingredient of cannabis)
( 19) Hashish
( 20) 2, 5 - dimethoxyamphetamine; 2, 5- DMA
( 21) 4- bromo- 2, 5- dimethoxy- amphetamine; 2,5- DMA
( 22) 4- methoxyamphetamine; PMA
( 23) Ethylamine N- ethyl- 1- phenylcyclohexylamine ( PCE)
( 24) Pyrrolidine 1-( 1- phenylcyclohexyl)- pyrrolidine ( PCPy), ( PHP) analog of the drug phencyclidine
( 25) Thiophene ( analog of phencyclidine) TCP or TPCP
( 26) Alpha- ethyltryptamine
( 27) 2, 5- dimethoxy- 4- ethylamphet- amine
( 29) Ibogaine
( 30) 2,5 dimethoxy- 4-( n)- propylthiophenethylamine ( 2C- T- 7)
( 31) Alpha- methyltryptamine ( AMT)
( 32) 5- methoxy- N, N- diisopropyltryptamine ( 5- MeO- DIPT)
D. DEPRESSANTS: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including its’ salts, isomers and salts of isomers whenever the existence of such salts, isomers and salts of isomers is possible within the specific chemical designation:
( 1) Mecloqualone
( 2) Methaqualone
( 3) Benzodiazepines
( a) bromazepam
( b) camazepam
( c) clobazam
( d) cloxazolam
( e) delorazepam
( f) ethyl loflazepate
( g) fludiazepam
( h) flunitrazepam
( i) haloxazolam
( j) ketazolam
( k) loprazolam
( l) lormetazepam
( m) medazepam
( n) nimetazepam
( o) nitrazepam
( p) nordiazepam
( q) oxazolam
( r) pinazepam
( s) tetrazepam
( 4) Gamma hydroxybutyric acid and any chemical compound that is metabolically converted to GHB.
( 5) Gamma butyrolactone and any chemical compound that is metabolically converted to GHB.
( 6) 1- 4 butane diol and any chemical compound that is metabolically converted to GHB.
E. STIMULANTS: Unless specifically exempted or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its’ salts, isomers, and salts of isomers.
( 1) Fenethylline
( 2) N- ethylamphetamine
( 3) cis- 4- methylaminorex
( 4) N, N- dimethylamphetamine
( 5) N- benzylpiperazine ( BZP, 1- benzylpiperazine) 21
F. Any material, compound, mixture of preparation which contains any quantity of the following substances.
( 1) 3- Methylfentanyl( N- 3- methyl- 1-( 2- phenyl- ethyl)- 4- Piperidyl)- N- phenylpropanamide, its’ optical and geometric isomers, salts and salts of isomers.
( 2) 3, 4- methylenedioxymethamphetamine ( MDMA), its’ optical, positional and geometric isomers, salts and salts of isomers.
( 3) 1- methyl- 4- phenyl- 4- proprionoxypiperidine ( MPPP), its’ optical isomers, salts, and salts of isomers.
( 4) 1-(- 2- phenylethyl)- 4- phenyl- 4- acetoxy piperidine ( PEPAP), its’ optical isomers, salts and salts of isomers.
( 5) Cathinone.
( 6) Methcathinone.
[ 16.19.20.65 NMAC - Rp 16 NMAC 19.20.28, 07- 15- 02; A, 06- 30- 05; A, 01- 15- 08]
16.19.20.66 SCHEDULE II:
A. Shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name or brand name designated, listed in this section. Substance, vegetable origin or chemical synthesis. Unless specifically exempt or unless listed in another schedule, any of the following substances whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis.
( 1) Opium and opiate, and any salts, compound, derivative, or preparation of opium or opiate excluding naloxone, dextrorphan, nalbuphine, naltrexone and apomorphine but including the following:
( a) raw opium
( b) opium extracts
( c) opium fluid extracts
( d) powdered opium
( e) granulated opium
( f) tincture of opium
( g) codeine
( h) ethylmorphine
( i) etorphine hydrochloride
( j) hydrocodone
( k) hydromorphone
( l) metopon
( m) morphine
( n) oxycodone
( o) oxymorphone
( p) thebaine
( q) alfentanil
( r) oripavine
( 2) Any salt, compound derivative, or preparation thereof, which is chemically equivalent or identical with any of the substances referred to in 16.19.20.66. A.( 1) NMAC, except that these substances shall not include the isoquinoline alkaloids of opium.
( 3) Opium poppy and poppy straw.
( 4) Coca leaves and any salt, compound, derivative or preparation of coca leaves and any salt, compound, derivative or preparation thereof which is chemically equivalent or identical with any of these substances, except that the substances shall not include de- cocainized coca leaves or extraction of coca leaves, which extractions do not contain cocaine or ecgonine.
B. OPIATES: Unless specifically excepted or unless in another schedule any of the following opiates, including its’ isomers, esters, ethers, salts and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation except dextrose and levopropoxyphene.
( 1) Alphaprodine
( 2) Anileridine
( 3) Bezitramide
22
( 4) Diphenoxylate
( 5) Dihydrocodeine
( 6) Dextropropoxyphene ( bulk) non- dosage form
( 7) Fentanyl
( 8) Isomethadone
( 9) Levomethorphan
( 10) Levorphanol
( 11) Metazocine
( 12) Methadone
( 13) Methadone- Intermediate
( 14) Monamide- Intermediate
( 15) Pethidine
( 16) Pethidine- Intermediate A
( 17) Pethidine- Intermediate B
( 18) Pethidine- Intermediate C
( 19) Phenazocine
( 20) Piminodine
( 21) Racemethorphan
( 22) Racemorphan
( 23) Sufentanil
( 24) Carfentanil
( 25) Levo- alphacetylmethadol ( LAAM)
( 26) Tapentadol
C. STIMULANTS: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system. ( See 16.19.21 NMAC- Drug Precursors)
( 1) Amphetamine, its’ salts, optical isomers and salts of its’ optical isomers.
( 2) Methamphetamine, its’ salts, isomers and salts of isomers.
( 3) Phenmetrazine and its’ salts.
( 4) Methylphenidate.
( 5) Lisdexamfetamine.
D. DEPRESSANTS: Unless specifically exempt or unless listed in another schedule any material, compound mixture or preparation which contains any quantity of the substance having a depressant effect on the central nervous system, including its’ salts, isomers and salts of isomers is possible within the specific chemical designation.
( 1) Amobarbital
( 2) Secobarbital
( 3) Pentobarbital
( 4) Phencyclidine
( 5) Dronabinol ( synthetic) - in sesame oil and encapsulated in soft gelatin capsules in a drug product approved by the U. S. Food and Drug Administration
( 6) Glutethimide
( 7) 1- phenylcyclohexylamine
( 8) 1- piperidinocyclohexanecarbonitrile
E. HALLUCINOGENIC SUBSTANCES: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation, which contains any quantity of the following hallucinogenic substances, or which contains any of its’ salts, isomers and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation ( for purpose of this paragraph only, the term “ isomers” includes the optical position, and geometric isomers): Nabilone
F. MISCELLANEOUS:
( 1) Dihydroetorphine
( 2) Bulk dextropropoxyphene
( 3) Remifentanil
[ 16.19.20.66 NMAC - Rp 16 NMAC 19.20.28( 1), 07- 15- 02; A, 06- 30- 05; A, 01- 15- 08]
23
16.19.20.67 SCHEDULE III: Shall Consist of Drugs and Other Substances, By Whatever Official Name, Common or Usual Name Designated Listed in This Section.
A. STIMULANTS: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system.
( 1) Those compounds, mixtures or preparations in dosage unit form containing any stimulant, amphetamine, phenmetrazine or methamphetamine previously exempt, for which the exemption was revoked by FDA Regulation Title 21, Part 308.13, and any other drug of the quantitative composition shown in that regulation for those drugs or which is the same except that it contains a lesser quantity of controlled substances.
( 2) Benzphetamine.
( 3) Phendimetrazine.
( 4) Chlorphentermine.
( 5) Clortermine.
B. DEPRESSANTS: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system.
( 1) Any compound, mixture or preparation containing:
( a) amobarbital;
( b) secobarbital;
( c) pentobarbital;
( d) butalbital; or any salt thereof and one or more active medicinal ingredients which are not listed in any schedule.
( 2) Any suppository dosage form containing:
( a) amobarbital;
( b) secobarbital;
( c) pentobarbital; or any salt of any of these drugs approved by the FDA for marketing only as a suppository.
( 3) Any substance which contains any quantity of a derivative of barbituric acid or any salt of a derivative of barbituric acid.
( 4) Chlorhexadol
( 5) Lysergic Acid
( 6) Lysergic Acid Amide
( 7) Methyprylon
( 8) Sulfondiethylmethane
( 9) Sulfonethylmethane
( 10) Sulfonmethane
( 11) Tiletamine/ zolazepam ( Telazol)
( 12) Ketamine Hydrochloride
( 13) Any drug product containing gamma hydroxybutyric acid, including its salts, isomers, and salts of isomers, for which an application is approved under section 505 of the Federal Food, Drug and Cosmetic Act.
( 14) Embutramide
C. Nalorphine ( a narcotic drug).
D. Buprenorphine.
E. NARCOTIC DRUGS: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation containing limited quantities of the following narcotic drugs, or any salts thereof.
( 1) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium.
( 2) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage units, with one or more active nonnarcotic ingredients in recognized therapeutic amounts.
( 3) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium.
( 4) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic
24
amounts.
( 5) Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
( 6) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
( 7) Not more than 500 milligrams of opium per 100 milliliters or per 100 grams or not more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
( 8) Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
F. ANABOLIC STEROIDS: The term “ anabolic steroid” means any drug or hormonal substance, chemically and pharmacologically related to testosterone ( other than estrogens, progestins, and corticosteroids) that promotes muscle growth. Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances listed in this section:
( 1) boldenone
( 2) chloro testosterone
( 3) clostebol
( 4) dehydrochlormethyltestosterone
( 5) dihydrotestosterone
( 6) drostanolone
( 7) ethylestrenol
( 8) fluoxymesterone
( 9) formebolone
( 10) mestanolone
( 11) mesterolone
( 12) methandienone
( 13) methandranone
( 14) methandriol
( 15) methandrostenolone
( 16) methenolone
( 17) methyltrienolone
( 18) methyltestosterone
( 19) mibolerone
( 20) nandrolone
( 21) norbolethone
( 22) norethandrolone
( 23) oxandrolone
( 24) oxymesterone
( 25) oxymetholone
( 26) stanolone
( 27) stanozolol
( 28) testolactone
( 29) testosterone
( 30) trenbolone; and
( 31) any salt, ester, or isomer of a drug or substance described or listed in this paragraph, if that salt, ester, or isomer promotes muscle growth.
G. Exempt Anabolic Steroids: Compounds, mixtures, or preparations that contain an anabolic steroid that have been exempted by the board from Subsection E of 16.19.20.67 NMAC, schedule III to the same extent that the substance has been exempted from the application of the Federal Controlled Substance Act, if the substance is listed as an exempt anabolic steroid product under 21 C. F. R. Section 1308.34 and its subsequent amendments.
[ 16.19.20.67 NMAC - Rp 16 NMAC 19.20.28( 2), 07- 15- 02; A, 02- 15- 03; A, 06- 30- 05; A, 01- 31- 07; A, 01- 15- 08]
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16.19.20.68 SCHEDULE IV: Shall Consist of the Drugs and Other Substances, by Whatever Official Name, Common or Usual Name, Chemical Name, or Brand Name Designated, Listed in this Section:
A. DEPRESSANTS: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances, including its’ salts, isomers, and salts of isomers whenever the existence of such salts, isomers and salts of isomers is possible within the specific chemical designation:
( 1) Alprazolam
( 2) Barbital
( 3) Chloral Betaine
( 4) Chloral Hydrate
( 5) Chlordiazepoxide
( 6) Clonazepam
( 7) Clorazepate
( 8) Clotiazepam
( 9) Diazepam
( 10) Estazolam
( 11) Ethchlorvynol
( 12) Ethinamate
( 13) Flurazepam
( 14) Halazepam
( 15) Lorazepam
( 16) Mebutamate
( 17) Meprobamate
( 18) Methohexital
( 19) Methylphenobarbital
( 20) Midazolam
( 21) Oxazepam
( 22) Paraldehyde
( 23) Petrichloral
( 24) Phenobarbital
( 25) Prazepam
( 26) Quazepam
( 27) Temazepam
( 28) Triazolam
( 29) Zopiclone
B. FENFLURAMINE: Any material, compound, mixture or preparation which contains any quantity of the following substance, including its’ salts, isomers ( whether optical position, or geometric) and its’ salts, or such isomers, whenever the existence of such salts, isomers, and salts of isomers is possible: Fenfluramine
C. STIMULANTS: Unless specifically exempt or unless listed in another schedule any material, compound, mixture or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its’ salts, isomers ( whether optical position, or geometric) and salts of such isomers whenever the existence of such salts, isomers and salts of isomers is possible within the specific chemical designation:
( 1) Diethylpropion
( 2) Phentermine
( 3) Pemoline ( including organometallic complexes and chelates thereon)
( 4) Pipradrol
( 5) SPA ((-)- 1- dimethyl amino- 1,2- diphenylmethane)
( 6) Mazindol
( 7) Cathine
( 8) Fencamfamin
( 9) Fenproporex
( 10) Mefenorex
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( 11) Modafinil
( 12) Sibutramine
D. OTHER SUBSTANCES: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances, including its’ salts:
( 1) Dextropropoxyphene( Alpha-(+)- 4- dimethylamino- 1,2- diphenyl- 3- methyl- 2- propionoxybutane)
( 2) Pentazocine
( 3) Carisoprodol
( 4) Nalbuphine Hydrochloride
( 5) Butorphanol Tartrate
( 6) Dezocine
( 7) Dichloralphenazone
( 8) Zaleplon
( 9) Zolpidem
E. NARCOTIC DRUG: Unless specifically exempt or unless listed in another schedule, any material, compound, mixture or preparation containing limited quantities of any of the following narcotic drugs or any salts thereof: Not more than 1 milligram of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.
F. EXEMPTION OF CHLORAL: When packaged in a sealed, oxygen- free environment, under nitrogen pressure, safeguarded against exposure to the air. Chloral when existing under the above conditions, is a substance which is not intended for general administration to a human being or another animal, and contains no narcotic controlled substances and is packaged in such a form that the package quantity does not present any significant potential for abuse. All persons who engage in industrial activities with respect to such chloral are subject to registration; but shall be exempt from Section 30- 31- 16 through 19 of the New Mexico Controlled Substances Act and 16.19.20.19 NMAC through 16.19.20.52 NMAC of the Board of Pharmacy regulations.
G. EXEMPT COMPOUNDS: Librax and Menrium are preparations which contain chlordiazepoxide, a depressant listed in Schedule IV, 16.19.20.68. A. 5 NMAC and other ingredients in such combinations, quantity, preparation or concentration as to vitiate the potential for abuse of chlordiazepoxide, and are hereby exempt preparations.
( 1) Librax
( 2) Menrium, 5- 2
( 3) Menrium, 4- 5
( 4) Menrium, 10- 4
[ 16.19.20.68 NMAC - Rp 16 NMAC 19.20.28( 3), 07- 15- 02; A, 06- 30- 05]
16.19.20.69 SCHEDULE V:
A. Narcotic drugs containing non- narcotic active medicinal ingredients. Any compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth below, which shall include one or more non- narcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by narcotic drugs alone.
( 1) Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams.
( 2) Not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams.
( 3) Not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100 grams.
( 4) Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit.
( 5) Not more than 100 milligrams of opium per 100 milliliters or per 100 grams.
( 6) Not more than 0.5 milligrams of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.
B. Stimulants. Unless specifically exempted or excluded or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers and salts of isomers.
( 1) Pyrovalerone.
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( 2) Pseudoephedrine as a drug that includes any compound, mixture, or preparation that contains any detectable quantity of pseudoephedrine, its salts or its optical isomers, or salts of its optical isomers. Pursuant to 30- 31- 10. C the following substances are excluded from Schedule V controlled substances: pseudoephedrine products in liquid form including liquid filled gel caps and pseudoephedrine products already classified as dangerous drugs.
C. Depressants. Unless specifically exempted or excluded or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts:
( 1) Lacosamide [( R)- 2- acetoamido- N- benzyl- 3- methoxy- propionamide]
( 2) Pregabalin [( S)- 3-( aminomethyl)- 5- methylhexanoic acid]
[ 16.19.20.69 NMAC - Rp 16 NMAC 19.20.28( 4), 07- 15- 02; A, 06- 30- 05; A, 06- 30- 06; A, 01- 31- 07]
16.19.20.70 EXEMPT DANGEROUS DRUGS ( PRESCRIPTION STATUS DRUGS): The drugs set forth in the Federal DEA Table of Excepted Prescription Drugs published in a separate volume under Code of Federal Regulations, Title 21, Chapter II, Part 1308.32 have been exempt by the New Mexico Board of Pharmacy. Any deviation from the quantitative composition of any of the listed drugs shall require a petition for exemption to the Federal DEA in order that a drug may be exempt by DEA and the New Mexico Board of Pharmacy.
[ 16.19.20.70 NMAC - Rp 16 NMAC 19.20.28( 5), 07- 15- 02]
HM 72- Salvia Divinorum: Mr. Harvey discussed the reported abuse of this plant due to its hallucinogenic properties. He stated that there would be a foolow- up with poison control and that the DEA has put this on their watchlist.
Proposed Change to 16.19.6 NMAC and a New Rule for “ change of ownership” for any business licensed pursuant to 61- 11- 14: Mr. Harvey discussed proposed language regarding the definition of “ ownership” and how it relates to transfers and new ownership.
Pharmacy Fund Transfer for NMMIP: Mr. Harvey stated that the funds were transferred over to the prescriptive drug program.
Proposed Addition of Euthanasia Technicians to 16.19.20.8( D) NMAC: Mr. Harvey discussed the registration requirement for euthanasia technicians to acquire a controlled substance license.
Motion:
A motion was made by Mr. Nunley, seconded by Ms. Saavedra to notice 16.19.20.8( D) at the October 2009 board meeting. The board voted unanimously to pass the motion.
ACPE Request for Observer: Mr. Harvey stated that he will pick up the forms.
Drug Take- Back Laws and Rules: Mr. Harvey stated that although the first drug take- back program was very successful, it must meet the requirements of the EDA. Mr. Harvey stated that Senator King was in favor of statute and rule changes and that more discussions regarding proposed language for 16.19.6.15 NMAC will be discussed in September.
Motion:
A motion was made by Ms. Saavedra, seconded by Mr. Ortega to notice 16.19.6.15 NMAC at the October 2009 board meeting. The board voted unanimously to pass the motion.
Update on Counseling Requirement: Mr. Harvey wrote an article for the newsletter regarding this subject.
HM 121: Soniclear ** inaudible**
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Pharmacist Prescriptive Authority: Ms. Disco presented language regarding prescriptive authority and emergency contraception relating to 16.19.26.10 NMAC.
Private/ Clinic Practice: Discussion was held regarding the “ patient bill of rights” and possible models being discussed in the committee as per Joe Anderson.
RECONVENE TUESDAY AUGUST 25TH, 2009:
The Chairman reconvened at 9: 00 a. m. and took roll call. Present were Mr. Anderson, Mr. Shaver, Mr. Nunley, Mr. Mazzoni, Ms. Buesing and Mr. Cross. Mr. Cross stated that Mr. Carrier and Mr. Ortega are running late and that a quorum is present.
SETTLEMENT AGREEMENTS/ SURRENDERS/ DEFAULT ORDERS:
2009- 035: A settlement agreement was presented to the board for Amanda Valencia.
Motion:
A motion was made by Mr. Nunley, seconded by Mr. Anderson to accept the settlement agreement for Amanda Valencia. The board voted unanimously to pass the motion.
2009- 097: The voluntary surrender for Howard N. Schwartz was presented to the board.
Motion:
A motion was made by Mr. Mazzoni, seconded by Mr. Nunley to accept the voluntary surrender for Howard N. Schwartz. The board voted unanimously to pass the motion.
2009- 102: The voluntary surrender was presented to the board for Robyn Salazar.
Motion:
A motion was made by Mr. Shaver, seconded by Ms. Buesing to accept the voluntary surrender for Howard N. Schwartz. The board voted unanimously to pass the motion.
The chairman stated that Mr. Carrier and Mr. Ortega were present at 9: 08 a. m.
EXECUTIVE DIRECTOR’S REPORT:
Open Meetings Resolution Adoption: Mr. Harvey presented the current resolution to the board.
Motion:
A motion was made by Ms. Buesing, seconded by Mr. Shaver to approve the resolution as presented. The board voted unanimously to pass the motion.
Board Meeting Dates: The board discussed the board meeting dates for 2010. The dates will be as follows;
Motion:
A motion was made by Mr. Ortega, seconded by Mr. Anderson to approve the 2010 board meeting dates. The board voted unanimously to pass the motion.
January 11th – 12th, 2010
March 15th - 16th, 2010
June 14th – 15th, 2010
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August 30th – 31st, 2010 Ruidoso
October 18th – 19th, 2010
GENERAL BOARD DISCUSSION/ OPEN SESSION/ GOALS FOR 2010:
Mr. Harvey and the board discussed a variety of issues regarding private practice, clinics, and pharmacy practices. Machine dispensing of drugs, pooling drugs and remote dispensing in hospitals was discussed. FYI, no action taken.
Ms. Buesing discussed language to be used for “ PSA’s” regarding medication safety and counseling by pharmacist. FYI, no action taken.
Mr. Harvey and Ms. Mary Smith discussed the issues regarding the jurisdiction of the pharmacy board pertaining to the one pharmacy at Sandia Labs that dispenses medication to the employees. Currently the pharmacy board does not have jurisdiction at Sandia Labs. FYI, no action taken.
The Chairman asked for a 10- minute recess at 10: 15 a. m.
RECESS:
RECONVENE:
The board reconvened at 10: 25 a. m.
Executive Director’s Report Cont’d:
Election of Officers: The board discussed the nominations for officers.
Motion:
A motion was made by Mr. Ortega, seconded by Mr. Mazzoni to elect Mr. Danny Cross as Chairman, Mr. Allen Carrier as Secretary and Ms. Amy Buesing as Vice- Chairman. The board voted unanimously to pass the motion.
Case Presentations:
Motion:
A motion was made by Mr. Ortega, seconded by Ms. Buesing to go into closed session to discuss case presentations. A roll call vote was taken. Mr. Ortega, Ms. Buesing, Mr. Mazzoni, Ms. Buesing, Mr. Mazzoni, Mr. Carrier, Mr. Nunlry, Mr. Shaver and Mr. Anderson voted unanimously to pass the motion.
The board went back into open session and the only issue discussed was case presentation.
Motion:
A motion was made by Ms. Buesing, seconded by Mr. Anderson to close cases as follows; 2008- 046, 2009- 035, 2009- 043, 2009- 057, 2009- 071, 2009- 098, 2009- 099, 2009- 042, 2009- 068, 2009- 080, 2009- 090, 2009- 097, 2008- 119, 2009- 055, 2009- 074, 2009- 081, 2009- 098, 2009- 102 and send advisory letter t; 2009- 067, 2009- 079, 2009- 098 and send NCA’s to; 2009- 031, 2009- 070, 2009- 085, 2009- 093, 2009- 072, 2009- 082 and to leave open; 2009- 083, 2009- 036. The board voted unanimously to pass the motion.
Motion:
A motion was made by Mr. Anderson, seconded by Mr. Nunley to adjourn the meeting. The board voted unanimously to pass the motion.
The board meeting was adjourned at 12: 15 p. m.